Chronic Hepatitis C
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of AL-335 in combination with odalasvir (ODV) with or without simeprevir (SMV) in participants with genotype (GT)1 or GT2 or GT3 chronic hepatitis C (CHC) infection.
Interventions
DRUGAL-335
AL-335 tablets will be administered in a dose range of 400 to 1200 mg once daily (QD).
DRUGOdalasvir (ODV)
ODV capsules will be administered in a dose range of 25 to 50 mg.
DRUGSimeprevir (SMV)
SMV tablets will be administered in a dose range of 75 to 150 mg QD or every other day (QOD).
Sponsors
Alios Biopharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Participant has provided written consent 2. In the Investigator's opinion, the participant is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned 3. Male or female, 18-70 years of age 4. Body mass index (BMI) 18-35 kilogram per meter square (kg/m\^2), inclusive 5. A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin) pregnancy test at screening 6. Female participants must either: * not be of childbearing potential defined as: i. Postmenopausal for at least 12 months (that is \[i.e.\], 2 years of amenorrhea without an alternative medical cause) and a serum follicle stimulating hormone (FSH) level in the postmenopausal range (per reference laboratory), OR ii. Surgically sterile (example \[e.g.\], underwent total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise incapable of becoming pregnant, OR * be of childbearing potential AND * not heterosexually active (e.g., abstinent or homosexual) from screening until 6 months after study drug administration (or longer, if dictated by local regulations), OR * if heterosexually active * have a vasectomized partner (confirmed sterile per verbal account of the participant), OR * using an acceptable method of birth control from screening and agree to continue to use the same method of contraception throughout the study and for 6 months after study drug administration (or longer, if dictated by local regulations). Oral hormone based contraceptives are not allowed from 14 days before the planned study drug administration until 6 months after the last dose of treatment due to the potential for drug-drug interactions which might undermine their efficacy. An intrauterine device (IUD), being either hormonal (i.e., Intra-Uterine System \[IUS\*\]) or non-hormonal, is considered highly effective and reliable; therefore participants using an IUD/IUS are not required to use additional contraceptive methods (no double-barrier method is required). Other non-oral hormone-based contraception methods (e.g., injectable, implants, transdermal system, vaginal ring) may be continued, but as the interaction of the study drug with hormone-based contraception is unknown, these methods are not considered to be reliable and therefore participants should use a double-barrier method (e.g., male condom+either diaphragm or cervical cap with or without spermicide). * An IUS does not rely on systemic plasma concentrations and is therefore not expected to be impacted by a potential drug-drug interaction (DDI) Note 1: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant. Note 2: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction 7. A post-menopausal female who is receiving hormone replacement therapy and is willing to discontinue hormone therapy 30 days before study drug dosing and agrees to remain off hormone replacement therapy for the duration of the study may be eligible for study participation. * Male participants must either: * be surgically sterile (had a vasectomy), or otherwise incapable of fathering a child, OR * not be heterosexually active (e.g., abstinent or homosexual) from enrollment (Day 1) in the study until at least 6 months after study drug administration, OR * if heterosexually active: * have a partner who is postmenopausal (2 years amenorrhea), surgically sterile (e.g., has had a total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise incapable of becoming pregnant OR * be practicing an acceptable method of birth control from enrollment in the study (Day 1) and agree to continue to use the same method of contraception throughout the study and for at least 6 months after study drug administration (or longer, if dictated by local regulations). An acceptable method of birth control for male participants is a double-barrier method (e.g., male condom+either diaphragm or cervical cap with or without spermicide). Note: Male participants with a female partner who uses hormonal contraceptives (oral, injectable, implants) or a hormonal (IUS) or non-hormonal IUD and male participants who are vasectomized or otherwise incapable of fathering a child are not required to use additional contraceptive methods. Note 1: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant. Note 2: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction. NOTE: Contraceptive use by men and women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies if these are stricter than what is proposed in these inclusion criteria 8. Participants must agree to refrain from sperm/egg donation from start of dosing through 6 months after the completion of study drug administration 9. Genotype (GT) 1a or 1b or GT2 or 3 chronic hepatitis C (CHC), depending on cohort, with positive Hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA) at screening including documentation of CHC infection for at least 6 months. Genotype testing must occur at a screening visit. NOTE: GT1 patients are eligible for inclusion even if they cannot be successfully subtyped unless a specific subtype is required for a cohort 10. Screening HCV RNA viral load greater than or equal to (\>=) 50,000 International Units per milliliter (IU/mL), except for participants with compensated cirrhosis (Child Pugh Class A) who may have HCV RNA viral load \>=10\^4 IU/mL 11. No prior treatment for CHC (defined as no prior exposure to any approved or investigational drug including direct-acting antivirals, and interferon-based treatments) 12. Fibroscan, collected within 6 months of baseline visit, with liver stiffness score less than or equal to (\<=) 12.5 kilo Pascal (kPa) to be eligible (except for participants with cirrhosis, see below). * participants with compensated cirrhosis must meet the Child-Pugh Class A definition (see Appendix G) and at least one of the following criteria: i. Liver biopsy result indicating the presence of cirrhosis (e.g., Metavir F4; Ishak \>5) or ii. Fibroscan evaluation with a liver stiffness score \>12.5 kPa 13. Participant is otherwise in good health as deemed by the investigator, based on the findings of a medical evaluation including medical history, physical examination, laboratory tests and electrocardiogram (ECG) 14. Willing to avoid prolonged sun exposure and use of tanning devices while taking Simeprevir (SMV) and through 4 weeks of follow up. Participant should also be advised to use a broad-spectrum sunscreen and lip balm of at least sun protection factor \>30 to help protect against potential sunburn
Exclusion criteria
1. Pregnant, planning on becoming pregnant (during treatment and up to 6 months after the end of treatment \[EOT\]), or breast-feeding female participant, or male participant whose female partner is pregnant or planning on becoming pregnant (during treatment and up to 6 months after the EOT) 2. Other than CHC with or without compensated cirrhosis, clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, thyroid or any other medical illness or psychiatric disorder, as determined by the Investigator and/or Sponsor's Medical Monitor 3. History or other clinical evidence of significant or unstable cardiac disease (e.g., angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant ECG abnormalities), moderate to severe valvular disease or uncontrolled hypertension at screening 4. Screening echocardiogram ejection fraction \<55 percentage (%) or any other echocardiographic finding suggestive of clinically relevant cardiomyopathy 5. Creatinine clearance of \<60 mL/min (Cockcroft-Gault) 6. Positive test for Hepatitis A virus immunoglobulin (HAV) Immunoglobulin M (IgM), Hepatitis B surface antigen (HBsAg), or Human Immunodeficiency Virus (HIV) Ab 7. Abnormal screening laboratory results that are considered clinically significant by the investigator 8. History of clinical hepatic decompensation, e.g., variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy or active jaundice (within last year) 9. Any condition that, in the opinion of the investigator, would compromise the study's objectives or the well-being of the participant or prevent the participant from meeting the study requirements 10. Participation in an investigational drug trial or having received an investigational vaccine within 30 days or 5 half lives (whichever is longer) prior to study medication 11. Clinically significant abnormal screening ECG findings (e.g., PR \>200 msec, QRS interval \>120 millisecond (msec) or corrected QT interval (QTc) \>450 msec for male participants and \>470 msec for female participants), based on an average of triplicate ECGs. Any evidence of heart block or bundle branch block is also exclusionary 12. History or family history of abnormal ECG intervals, for example prolonged QT syndrome (torsade de pointes) or sudden cardiac death 13. The participant has a positive prestudy drug screen, including methadone unless the drug is prescribed by the participant's physician. The list of drugs that should be screened for includes amphetamines, barbiturates, cocaine, opiates, phencyclidine (PCP), and benzodiazepines 14. Laboratory abnormalities including: * Hematocrit \<0.34 * White blood cell counts \<3,500/millimeter (mm)\^3 (\<1,000/mm\^3 for participants with compensated cirrhosis) * Absolute neutrophil count \<1,000/mm\^3 (\<750/mm\^3 for participants with compensated cirrhosis) * Platelets \<=120,000/mm\^3 (platelets ≤90,000/mm\^3 for participants with compensated cirrhosis) * Glycosylated hemoglobin (HbA1C) \>55 mmol/mol * Prothrombin time \>=1.5 \* upper limit of normal (ULN) * Albumin \<=32 gram per liter (g/L), bilirubin \>=1.5 milligram per deciliter (mg/dL) at screening (participants with documented Gilbert's disease allowed) * Serum ALT concentration \>=5\* ULN * CK \>1.5\* ULN A single repeat laboratory evaluation under appropriate conditions (e.g., fasted, no antecedent exercise) is allowed for eligibility determination 15. Any condition possibly affecting drug absorption (e.g., gastrectomy or other significant gastrointestinal tract surgery, such as gastroenterostomy, small bowel resection, or active enterostomy) 16. Clinically significant blood loss or elective blood donation of significant volume (i.e., \>500 mL) within 60 days of first dose of study drug; \>1 unit of plasma within 7 days of first dose of study drug 17. Evidence of clinically relevant active infection that would interfere with study conduct or its interpretation 18. History of regular alcohol intake \>10 standard drinks per week of alcohol for females and \>15 standard drinks per week for males (one unit is defined as 10 g alcohol) within 3 months of the screening visit 19. The use of prohibited medications, including prescription, over the counter (OTC) medications, herbal medications, inducers or inhibitors of Cytochrome P450 (CYP450) enzymes or drug transporters (including P-gp) within 14 days prior to the first dose of study medication is excluded, unless previously approved by the Sponsor's Medical Monitor. NOTE: Chronic medication use is permitted so long as they are medically necessary, deemed acceptable by the Principal Investigator and Medical Monitor, and not Prohibited Medications (see Section 5.12) 20. Hypersensitivity to the active substances (including sulfa allergy) or to any of the excipients of AL-335, Odalasvir (ODV) or SMV 21. Evidence on recent (within 6 months) liver ultrasound of hepatic mass or lesion concerning for malignancy (participants with cirrhosis only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Event (TEAE) | Up to 43 weeks | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between administration of study drug and up to 43 weeks that were absent before treatment or that worsened relative to pre-treatment state. |
| Body Weight at End of Treatment | End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks) | Body weight (measured using a calibrated scale) at end of treatment was reported. |
| Body Mass Index (BMI) at End of Treatment | End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks) | BMI was calculated by dividing the body weight (in kilogram) by the square of height (in meters). BMI at end of treatment was reported. |
| Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Up to 43 weeks | Percentage of participants with worst post-baseline values of vital signs (Systolic blood pressure \[sBP\], Diastolic blood pressure \[dBP\], and Heart rate) were reported. For sBP, abnormally low: less than or equal to \[\<=\] 90 millimeters mercury \[mmHg\]; Grade 1 or mild: greater than \[\>\] 140 to less than \[\<\] 160 mmHg; Grade 2 or moderate: \>=160 to \<180 and Grade 3 or severe: \>=180 mmHg. For dBP, abnormally low: \<=50 mmHg; Grade 1 or mild: \>90 to \<100 mmHg; Grade 2 or moderate: \>=100 to \<110 mmHg and Grade 3 or severe: \>=110 mmHg. For Heart Rate, abnormally low: \<=50 beats per minute \[bpm\] and abnormally high: \>=120 bpm. |
| Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Baseline up to End of treatment (up to 43 weeks) | Percentage of participants with maximum decrease from baseline in mean ejection fraction was reported. Percentages are based on the number of participants with available data. |
| Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Up to 43 weeks | Percentage of participants by treatment emergent toxicity grade (1, 2, 3, 4 and 3+4) for Hematology parameters (hemoglobin, lymphocytes, neutrophils, leukocytes, platelets) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing. |
| Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Up to 43 weeks | Percentage of participants by treatment emergent toxicity grade (Grade 1,2,3,4,3+4) for Blood Chemistry (Calcium, Phosphate, Potassium, Sodium, Bicarbonate, Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Direct bilirubin, Glucose, Cholesterol, Triglycerides, Urate, Triacylglycerol lipase, Creatinine, Creatinine clearance, Albumin and Creatine kinase) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing. |
| Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Up to 43 weeks | Percentage of participants by treatment emergent toxicity grade for coagulation parameter (Prothrombin International Normalized Ratio) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing. |
| Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Up to 43 weeks | Percentage of participants by treatment emergent toxicity grade (Grade 1, 2, 3, 4, 3+4) for urinalysis parameter (protein) was reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing. |
| Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Up to 43 weeks | Percentage of participants with worst treatment emergent abnormalities of ECG parameters (Fridericia Corrected QT interval \[QTcF\], Bazett Corrected QT interval \[QTcB\], Heart rate, QRS and PR, was reported. For QTcF abnormality was defined as 30 milliseconds (ms) less than or equal to (\<=) QTcF increase from baseline \<= 60 ms; for QTcB abnormality was defined as 30 ms \<= QTcB increase from baseline \<= 60 ms; for heart rate - abnormal low: \<= 50 beats per minute (bpm) and abnormal high: \>= 120 bpm; for QRS - abnormal high: \>120 ms; for PR - abnormally low: PR \< 120 ms; abnormally high - 200 ms \< PR \<= 240 ms and 240 ms \< PR \<= 300 ms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmin of Simeprevir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Cmin is the minimum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Cmax of Simeprevir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Cmax is the maximum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Ctrough of Simeprevir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Ctrough is the trough plasma concentration of Simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Tmax of Simeprevir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Tmax is the Time to reach the maximum plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| AUC (0-last) of Simeprevir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | AUC (0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| AUC (0-24) of Simeprevir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose | AUC (0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Clast of Simeprevir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Clast is the maximum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Tlast of Simeprevir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Tlast is the time corresponding to last measurable plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Average Plasma Concentration at Steady State (Css,Avg) of Simeprevir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Css,avg is the average plasma concentration at steady state of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Cmin of Odalasvir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Cmin is the minimum observed plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Cmax of Odalasvir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Cmax is the maximum observed plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Ctrough of Odalasvir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Ctrough is the trough plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Tmax of Odalasvir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Tmax is the time to reach the maximum plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| AUC (0-last) of Odalasvir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | AUC(0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| AUC (0-24) for Odalasvir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose | AUC(0-24) is the area under the plasma concentration-time curve from time zero to time 24 hours for odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Clast of Odalasvir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Clast is the last measurable plasma concentration (Clast) of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Tlast of Odalasvir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Tlast is the time corresponding to last measurable plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | At Week 4, 12 and Week 24 after end of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks) | Participants were considered to have achieved SVR if the Hepatitis C virus (HCV) Ribonucleic acid (RNA) less than (\<) Lower limit of quantification (LLOQ) (\<15 international unit per milliliter \[IU/mL\]) detectable or undetectable at Week 4, 12 and 24 after the actual end of study drug treatment. |
| Percentage of Participants With Virologic Relapse During the Follow-up Period | Follow up period (Up to Week 12 after end of treatment) | Viral relapse is defined as participants SVR12, with HCV RNA \<LLOQ at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (\>=) LLOQ during follow up. |
| Percentage of Participants With On-treatment Failure | Up to 12 weeks | On-treatment failure was defined by participants who did not achieve SVR12 and with confirmed HCV RNA \>= LLOQ at the actual end of study drug treatment. |
| Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks) | Percentage of participants who achieved HCV RNA less then (\<) LLOQ undetectable was reported. |
| Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks) | Percentage of participants who achieved HCV RNA \<LLOQ was reported. |
| Time to Achieve Undetectable HCV RNA or < LLOQ HCV RNA | Up to Week 24 (follow up visit) | Time to achieve undetectable HCV RNA or \< LLOQ HCV RNA was reported. |
| Number of Participants With HCV Nonstructural Protein NS5A, NS5B, and NS3/4A Sequence in Participants With Virologic Failure | Up to Week 24 (Follow up visit) | Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants with virologic failure. |
| Average Plasma Concentration at Steady State (Css,Avg) of Odalasvir | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Css,avg is the average plasma concentration at steady state of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Cmin is the minimum observed plasma concentration of AL-335 and its metabolites (ALS-022399 and ALS-022227). For Pharmacokinetic (PK) analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Cmax is the maximum observed plasma concentration of AL-335 and its metabolites (ALS-022227). For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Ctrough is the trough plasma concentration for AL-335 and its metabolites (ALS-022399 and ALS-022227). For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Tmax is the time to reach the maximum plasma concentration of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | AUC(0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose | AUC(0-24) is the area under the plasma concentration-time curve from time zero to time 24 hours for AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Clast is the last measurable plasma concentration (Clast) of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Tlast is the time corresponding to last measurable plasma concentration for AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
| Average Plasma Concentration at Steady State (Css,Avg) of ALS-022227 | Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8) | Css,avg is the average plasma concentration at steady state of ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11). |
Countries
Mauritius, Moldova, New Zealand, United Kingdom
Participant flow
Recruitment details
No participants were recruited for Cohorts 10 and 12, hence no data is reported here for these two cohorts.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks. | 20 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks. | 25 |
| Cohort 2 (8 Weeks GT1) Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks. | 20 |
| Cohort 3 (6 Weeks GT1) Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks. | 20 |
| Cohort 4 (12 Weeks GT1) Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks. | 8 |
| Cohort 5a (8 Weeks GT3) Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks. | 5 |
| Cohort 5b (12 Weeks GT3) Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks. | 14 |
| Cohort 6,7,8 (8 Weeks GT1 F4) Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks. | 30 |
| Cohort 9 (12 Weeks GT1 F4) Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks. | 15 |
| Cohort 11 (12 Weeks GT2 F4) Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks. | 4 |
| Total | 161 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Overall Study | Virologic failure | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1 (8 Weeks Genotype [GT1]) | Cohort 1b + Cohort 4 (8 Weeks GT1) | Cohort 2 (8 Weeks GT1) | Cohort 3 (6 Weeks GT1) | Cohort 4 (12 Weeks GT1) | Cohort 5a (8 Weeks GT3) | Cohort 5b (12 Weeks GT3) | Cohort 6,7,8 (8 Weeks GT1 F4) | Cohort 9 (12 Weeks GT1 F4) | Cohort 11 (12 Weeks GT2 F4) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 56 years | 55 years | 56 years | 55.5 years | 55 years | 54 years | 44.5 years | 56.5 years | 52 years | 63.5 years | 55 years |
| Race/Ethnicity, Customized Asian | 0 Participants | 4 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 13 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 3 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 10 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants | 0 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 20 Participants | 17 Participants | 18 Participants | 14 Participants | 6 Participants | 2 Participants | 12 Participants | 27 Participants | 9 Participants | 3 Participants | 128 Participants |
| Region of Enrollment Mauritius | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 6 Participants | 0 Participants | 8 Participants |
| Region of Enrollment Moldova | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 13 Participants | 3 Participants | 0 Participants | 16 Participants |
| Region of Enrollment New Zealand | 20 Participants | 25 Participants | 20 Participants | 20 Participants | 8 Participants | 5 Participants | 14 Participants | 14 Participants | 5 Participants | 3 Participants | 134 Participants |
| Region of Enrollment United Kingdom | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 6 Participants | 8 Participants | 5 Participants | 0 Participants | 1 Participants | 16 Participants | 2 Participants | 1 Participants | 54 Participants |
| Sex: Female, Male Male | 13 Participants | 17 Participants | 14 Participants | 12 Participants | 3 Participants | 5 Participants | 13 Participants | 14 Participants | 13 Participants | 3 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 25 | 0 / 20 | 0 / 20 | 0 / 8 | 0 / 5 | 0 / 14 | 0 / 30 | 0 / 15 | 0 / 4 |
| other Total, other adverse events | 17 / 20 | 20 / 25 | 14 / 20 | 14 / 20 | 7 / 8 | 4 / 5 | 13 / 14 | 18 / 30 | 10 / 15 | 4 / 4 |
| serious Total, serious adverse events | 1 / 20 | 2 / 25 | 0 / 20 | 0 / 20 | 0 / 8 | 0 / 5 | 0 / 14 | 1 / 30 | 2 / 15 | 1 / 4 |
Outcome results
Primary
Body Mass Index (BMI) at End of Treatment
BMI was calculated by dividing the body weight (in kilogram) by the square of height (in meters). BMI at end of treatment was reported.
Time frame: End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Here, N (number of participants analyzed) signifies number of participants evaluable for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Body Mass Index (BMI) at End of Treatment | 25.89 Kilograms per square meter (Kg/m^2) | Standard Deviation 4.63 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Body Mass Index (BMI) at End of Treatment | 28.43 Kilograms per square meter (Kg/m^2) | Standard Deviation 4.26 |
| Cohort 2 (8 Weeks GT1) | Body Mass Index (BMI) at End of Treatment | 26.45 Kilograms per square meter (Kg/m^2) | Standard Deviation 5.53 |
| Cohort 3 (6 Weeks GT1) | Body Mass Index (BMI) at End of Treatment | 25.46 Kilograms per square meter (Kg/m^2) | Standard Deviation 3.53 |
| Cohort 4 (12 Weeks GT1) | Body Mass Index (BMI) at End of Treatment | 25.60 Kilograms per square meter (Kg/m^2) | Standard Deviation 3.21 |
| Cohort 5a (8 Weeks GT3) | Body Mass Index (BMI) at End of Treatment | 25.60 Kilograms per square meter (Kg/m^2) | Standard Deviation 2.82 |
| Cohort 5b (12 Weeks GT3) | Body Mass Index (BMI) at End of Treatment | 26.17 Kilograms per square meter (Kg/m^2) | Standard Deviation 4.2 |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Body Mass Index (BMI) at End of Treatment | 27.69 Kilograms per square meter (Kg/m^2) | Standard Deviation 5.28 |
| Cohort 9 (12 Weeks GT1 F4) | Body Mass Index (BMI) at End of Treatment | 27.98 Kilograms per square meter (Kg/m^2) | Standard Deviation 4.37 |
| Cohort 11 (12 Weeks GT2 F4) | Body Mass Index (BMI) at End of Treatment | 23.64 Kilograms per square meter (Kg/m^2) | Standard Deviation 4.5 |
Primary
Body Weight at End of Treatment
Body weight (measured using a calibrated scale) at end of treatment was reported.
Time frame: End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Here, N (number of participants analyzed) signifies number of participants evaluable for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Body Weight at End of Treatment | 76.02 Kilograms (kg) | Standard Deviation 15.13 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Body Weight at End of Treatment | 84.58 Kilograms (kg) | Standard Deviation 15.09 |
| Cohort 2 (8 Weeks GT1) | Body Weight at End of Treatment | 80.19 Kilograms (kg) | Standard Deviation 17.79 |
| Cohort 3 (6 Weeks GT1) | Body Weight at End of Treatment | 74.07 Kilograms (kg) | Standard Deviation 12.78 |
| Cohort 4 (12 Weeks GT1) | Body Weight at End of Treatment | 73.09 Kilograms (kg) | Standard Deviation 8.62 |
| Cohort 5a (8 Weeks GT3) | Body Weight at End of Treatment | 81.30 Kilograms (kg) | Standard Deviation 13.82 |
| Cohort 5b (12 Weeks GT3) | Body Weight at End of Treatment | 81.83 Kilograms (kg) | Standard Deviation 13.67 |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Body Weight at End of Treatment | 80.15 Kilograms (kg) | Standard Deviation 17.92 |
| Cohort 9 (12 Weeks GT1 F4) | Body Weight at End of Treatment | 86.02 Kilograms (kg) | Standard Deviation 15.56 |
| Cohort 11 (12 Weeks GT2 F4) | Body Weight at End of Treatment | 69.90 Kilograms (kg) | Standard Deviation 11.55 |
Primary
Number of Participants With Treatment Emergent Adverse Event (TEAE)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between administration of study drug and up to 43 weeks that were absent before treatment or that worsened relative to pre-treatment state.
Time frame: Up to 43 weeks
Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Number of Participants With Treatment Emergent Adverse Event (TEAE) | 17 Participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Number of Participants With Treatment Emergent Adverse Event (TEAE) | 19 Participants |
| Cohort 2 (8 Weeks GT1) | Number of Participants With Treatment Emergent Adverse Event (TEAE) | 14 Participants |
| Cohort 3 (6 Weeks GT1) | Number of Participants With Treatment Emergent Adverse Event (TEAE) | 13 Participants |
| Cohort 4 (12 Weeks GT1) | Number of Participants With Treatment Emergent Adverse Event (TEAE) | 7 Participants |
| Cohort 5a (8 Weeks GT3) | Number of Participants With Treatment Emergent Adverse Event (TEAE) | 4 Participants |
| Cohort 5b (12 Weeks GT3) | Number of Participants With Treatment Emergent Adverse Event (TEAE) | 13 Participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Number of Participants With Treatment Emergent Adverse Event (TEAE) | 17 Participants |
| Cohort 9 (12 Weeks GT1 F4) | Number of Participants With Treatment Emergent Adverse Event (TEAE) | 10 Participants |
| Cohort 11 (12 Weeks GT2 F4) | Number of Participants With Treatment Emergent Adverse Event (TEAE) | 4 Participants |
Primary
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Percentage of participants by treatment emergent toxicity grade (Grade 1,2,3,4,3+4) for Blood Chemistry (Calcium, Phosphate, Potassium, Sodium, Bicarbonate, Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Direct bilirubin, Glucose, Cholesterol, Triglycerides, Urate, Triacylglycerol lipase, Creatinine, Creatinine clearance, Albumin and Creatine kinase) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Time frame: Up to 43 weeks
Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 2 | 5.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 1 | 5.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3 | 5.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 2 | 15.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 2 | 15.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 1 | 15.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 1 | 5.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 1 | 5.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 1 | 20.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 2 | 10.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 1 | 5.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3+4 | 5.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 1 | 16.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 1 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 2 | 4.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 1 | 4.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 2 | 20.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 1 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 2 | 4.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 2 | 8.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 1 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 1 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 1 | 12.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 1 | 4.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 2 | 8.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 2 | 4.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 1 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 1 | 16.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3 | 8.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 1 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 1 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 1 | 12.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 1 | 8.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 1 | 4.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 1 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 1 | 24.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3+4 | 8.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 1 | 10.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 2 | 5.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 1 | 30.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3 | 5.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3+4 | 5.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3+4 | 5.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 2 | 5.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 1 | 5.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 1 | 5.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 1 | 10.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 1 | 15.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 1 | 10.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 1 | 5.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 2 | 10.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 4 | 5.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 2 | 25.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 1 | 10.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 1 | 5.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 2 | 5.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 2 | 5.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 2 | 5.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 1 | 15.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 1 | 35.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 1 | 5.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 2 | 15.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 2 | 37.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 2 | 12.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 1 | 25.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 1 | 12.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 2 | 12.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 1 | 12.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 1 | 25.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 2 | 12.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3 | 12.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 1 | 12.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 1 | 12.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3+4 | 12.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 1 | 50.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 1 | 12.5 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 1 | 20.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 1 | 20.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 1 | 20.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 1 | 20.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 1 | 35.7 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 1 | 7.1 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 1 | 28.6 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 2 | 14.3 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 2 | 14.3 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 1 | 42.9 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3+4 | 21.4 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 1 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 1 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 2 | 7.1 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 1 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 2 | 14.3 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 1 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 2 | 7.1 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 1 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 1 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 1 | 3.3 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 1 | 7.1 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 1 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 1 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3 | 21.4 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 1 | 28.6 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 1 | 7.1 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 1 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 1 | 6.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 1 | 10.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 2 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 1 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 2 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 2 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3+4 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 2 | 6.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3+4 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 1 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 2 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 2 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 1 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 2 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 1 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 1 | 6.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 2 | 13.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3+4 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3+4 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 1 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 2 | 13.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3+4 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 2 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 2 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 2 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 2 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 2 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 1 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 1 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 1 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 1 | 16.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 1 | 13.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 4 | 6.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 1 | 13.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 2 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 1 | 10.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 1 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3+4 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3+4 | 6.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 2 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 2 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 1 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 2 | 6.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3 | 6.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 1 | 13.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 2 | 6.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3 | 6.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 1 | 33.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 1 | 20.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 2 | 20.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 2 | 6.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 1 | 20.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 1 | 26.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 2 | 13.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3+4 | 6.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3+4 | 6.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 2 | 6.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 2 | 25.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 1 | 25.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 2 | 25.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bicarbonate: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 1 | 50.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Glucose: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Urate: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Potassium: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Calcium: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Sodium: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatine kinase: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Aspartate aminotransferase: Grade: 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alkaline phosphatase: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 1 | 25.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Albumin: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Phosphate: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triacylglycerol lipase: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Bilirubin: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Alanine aminotransferase: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Creatinine clearance: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Triglycerides: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Cholesterol: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters | Direct bilirubin: Grade 3 | 0.0 Percentage of participants |
Primary
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Percentage of participants by treatment emergent toxicity grade (1, 2, 3, 4 and 3+4) for Hematology parameters (hemoglobin, lymphocytes, neutrophils, leukocytes, platelets) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Time frame: Up to 43 weeks
Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 1 | 5.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 1 | 5.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 1 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 1 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 1 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 1 | 5.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 1 | 5.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 1 | 5.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 1 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 1 | 7.1 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 1 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 2 | 7.1 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 2 | 10.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 1 | 6.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 1 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 2 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 2 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 1 | 6.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 2 | 16.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 1 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 1 | 10.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 1 | 13.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Neutrophils: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Lymphocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Platelets: Grade 1 | 25.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 3 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Leukocytes: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters | Hemoglobin: Grade 3+4 | 0.0 Percentage of participants |
Primary
Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR)
Percentage of participants by treatment emergent toxicity grade for coagulation parameter (Prothrombin International Normalized Ratio) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Time frame: Up to 43 weeks
Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 2 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 4 | 4.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3+4 | 4.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 1 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 2 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 1 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 1 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 2 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 1 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR) | Prothrombin INR: Grade 3 | 0.0 Percentage of participants |
Primary
Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein)
Percentage of participants by treatment emergent toxicity grade (Grade 1, 2, 3, 4, 3+4) for urinalysis parameter (protein) was reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Time frame: Up to 43 weeks
Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 1 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 2 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 4 | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 1 | 4.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 2 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 1 | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 1 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 2 | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 2 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 1 | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 1 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 2 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 4 | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 1 | 7.1 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 2 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 4 | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 2 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 1 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 4 | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3 | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3+4 | 3.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3+4 | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 2 | 13.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 1 | 26.7 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 4 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 2 | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3 | 25.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 1 | 50.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein) | Protein: Grade 3+4 | 25.0 Percentage of participants |
Primary
Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction
Percentage of participants with maximum decrease from baseline in mean ejection fraction was reported. Percentages are based on the number of participants with available data.
Time frame: Baseline up to End of treatment (up to 43 weeks)
Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of > 10% | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >0-<=5% | 65.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >5-<=10% | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >5-<=10% | 4.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of > 10% | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >0-<=5% | 48.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of > 10% | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >5-<=10% | 10.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >0-<=5% | 60.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >0-<=5% | 50.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of > 10% | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >5-<=10% | 10.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >5-<=10% | 12.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >0-<=5% | 50.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of > 10% | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of > 10% | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >5-<=10% | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >0-<=5% | 20.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of > 10% | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >0-<=5% | 64.3 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >5-<=10% | 21.4 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of > 10% | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >0-<=5% | 80.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >5-<=10% | 3.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >5-<=10% | 6.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >0-<=5% | 46.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of > 10% | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >0-<=5% | 50.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of >5-<=10% | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction | Decline of > 10% | 0.0 Percentage of participants |
Primary
Percentage of Participants With Worst Post-Baseline Values of Vital Signs
Percentage of participants with worst post-baseline values of vital signs (Systolic blood pressure \[sBP\], Diastolic blood pressure \[dBP\], and Heart rate) were reported. For sBP, abnormally low: less than or equal to \[\<=\] 90 millimeters mercury \[mmHg\]; Grade 1 or mild: greater than \[\>\] 140 to less than \[\<\] 160 mmHg; Grade 2 or moderate: \>=160 to \<180 and Grade 3 or severe: \>=180 mmHg. For dBP, abnormally low: \<=50 mmHg; Grade 1 or mild: \>90 to \<100 mmHg; Grade 2 or moderate: \>=100 to \<110 mmHg and Grade 3 or severe: \>=110 mmHg. For Heart Rate, abnormally low: \<=50 beats per minute \[bpm\] and abnormally high: \>=120 bpm.
Time frame: Up to 43 weeks
Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally low | 35.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Abnormally low | 0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Abnormally low | 0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 1 or mild | 20.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 1 or mild | 5.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 2 or moderate | 10.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 3 or severe | 0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally high | 0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 3 or severe | 0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 2 or moderate | 5.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 1 or mild | 32.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally low | 32.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 1 or mild | 20.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 2 or moderate | 12.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 3 or severe | 4.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Abnormally low | 0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 2 or moderate | 8.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally high | 0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 3 or severe | 0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Abnormally low | 4.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Abnormally low | 0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 3 or severe | 0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Abnormally low | 0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally high | 0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 2 or moderate | 0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally low | 35.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 1 or mild | 35.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 2 or moderate | 0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 3 or severe | 5.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 1 or mild | 35.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 1 or mild | 25.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 3 or severe | 0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally high | 0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 2 or moderate | 0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Abnormally low | 0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Abnormally low | 0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 2 or moderate | 5.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 1 or mild | 20.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally low | 30.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 3 or severe | 0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 2 or moderate | 0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 3 or severe | 25.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 3 or severe | 0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 1 or mild | 37.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 2 or moderate | 37.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally high | 12.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 1 or mild | 0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally low | 50.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Abnormally low | 0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Abnormally low | 12.5 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 3 or severe | 0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 1 or mild | 60.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 2 or moderate | 0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally low | 20.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 2 or moderate | 0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally high | 0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 1 or mild | 60.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Abnormally low | 0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 3 or severe | 0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Abnormally low | 0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 1 or mild | 21.4 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 3 or severe | 7.1 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally high | 0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Abnormally low | 0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 1 or mild | 57.1 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 2 or moderate | 7.1 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 3 or severe | 0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Abnormally low | 0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 2 or moderate | 14.3 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally low | 21.4 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 3 or severe | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 2 or moderate | 13.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 1 or mild | 26.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally high | 0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Abnormally low | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 1 or mild | 10.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 3 or severe | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Abnormally low | 0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 2 or moderate | 20.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally low | 13.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Abnormally low | 0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 3 or severe | 13.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 2 or moderate | 13.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 1 or mild | 26.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 3 or severe | 6.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Abnormally low | 0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 1 or mild | 46.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally low | 13.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally high | 0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 2 or moderate | 6.7 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 3 or severe | 0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 1 or mild | 25.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 1 or mild | 0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 2 or moderate | 25.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Grade 2 or moderate | 50.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | sBP: Abnormally low | 0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Abnormally low | 0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | dBP: Grade 3 or severe | 0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally high | 0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Post-Baseline Values of Vital Signs | Heart Rate: Abnormally low | 0 Percentage of participants |
Primary
Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters
Percentage of participants with worst treatment emergent abnormalities of ECG parameters (Fridericia Corrected QT interval \[QTcF\], Bazett Corrected QT interval \[QTcB\], Heart rate, QRS and PR, was reported. For QTcF abnormality was defined as 30 milliseconds (ms) less than or equal to (\<=) QTcF increase from baseline \<= 60 ms; for QTcB abnormality was defined as 30 ms \<= QTcB increase from baseline \<= 60 ms; for heart rate - abnormal low: \<= 50 beats per minute (bpm) and abnormal high: \>= 120 bpm; for QRS - abnormal high: \>120 ms; for PR - abnormally low: PR \< 120 ms; abnormally high - 200 ms \< PR \<= 240 ms and 240 ms \< PR \<= 300 ms.
Time frame: Up to 43 weeks
Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal low | 25.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcF: Abnormal | 5.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcB: Abnormal | 5.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal high | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QRS: Abnormal high | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally low (PR<120 ms) | 0.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally high (200 ms<PR<= 240 ms) | 5.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormal high (240 ms<PR<=300 ms) | 10.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally low (PR<120 ms) | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcF: Abnormal | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormal high (240 ms<PR<=300 ms) | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal high | 0.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal low | 16.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcB: Abnormal | 8.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally high (200 ms<PR<= 240 ms) | 8.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QRS: Abnormal high | 4.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal high | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormal high (240 ms<PR<=300 ms) | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally high (200 ms<PR<= 240 ms) | 15.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally low (PR<120 ms) | 0.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcF: Abnormal | 5.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal low | 10.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcB: Abnormal | 10.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QRS: Abnormal high | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally low (PR<120 ms) | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal high | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QRS: Abnormal high | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally high (200 ms<PR<= 240 ms) | 10.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcB: Abnormal | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcF: Abnormal | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormal high (240 ms<PR<=300 ms) | 0.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal low | 15.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcF: Abnormal | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcB: Abnormal | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally high (200 ms<PR<= 240 ms) | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal low | 25.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormal high (240 ms<PR<=300 ms) | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal high | 12.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QRS: Abnormal high | 0.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally low (PR<120 ms) | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcF: Abnormal | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal high | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally low (PR<120 ms) | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QRS: Abnormal high | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcB: Abnormal | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally high (200 ms<PR<= 240 ms) | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormal high (240 ms<PR<=300 ms) | 0.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal low | 20.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal high | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal low | 14.3 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QRS: Abnormal high | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally high (200 ms<PR<= 240 ms) | 0.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcF: Abnormal | 7.1 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcB: Abnormal | 28.6 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally low (PR<120 ms) | 7.1 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormal high (240 ms<PR<=300 ms) | 7.1 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcF: Abnormal | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcB: Abnormal | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal low | 13.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal high | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QRS: Abnormal high | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormal high (240 ms<PR<=300 ms) | 0.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally low (PR<120 ms) | 3.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally high (200 ms<PR<= 240 ms) | 6.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally high (200 ms<PR<= 240 ms) | 13.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal high | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally low (PR<120 ms) | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal low | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcF: Abnormal | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcB: Abnormal | 6.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QRS: Abnormal high | 0.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormal high (240 ms<PR<=300 ms) | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal high | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QRS: Abnormal high | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally high (200 ms<PR<= 240 ms) | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormal high (240 ms<PR<=300 ms) | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | PR: Abnormally low (PR<120 ms) | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | Heart rate: Abnormal low | 25.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcB: Abnormal | 0.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters | QTcF: Abnormal | 0.0 Percentage of participants |
Secondary
Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
AUC(0-24) is the area under the plasma concentration-time curve from time zero to time 24 hours for AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 2897.0 ng*h/mL | Standard Deviation 1081.8 |
| Cohort 1 (8 Weeks Genotype [GT1]) | Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 500.5 ng*h/mL | Standard Deviation 230.8 |
| Cohort 1 (8 Weeks Genotype [GT1]) | Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 1058.0 ng*h/mL | Standard Deviation 886.9 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 3238.2 ng*h/mL | Standard Deviation 972.8 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 1197.2 ng*h/mL | Standard Deviation 507.7 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 718.0 ng*h/mL | Standard Deviation 240.7 |
| Cohort 2 (8 Weeks GT1) | Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 1532.7 ng*h/mL | Standard Deviation 1329.5 |
| Cohort 2 (8 Weeks GT1) | Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 1009.7 ng*h/mL | Standard Deviation 599.4 |
| Cohort 2 (8 Weeks GT1) | Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 5258.1 ng*h/mL | Standard Deviation 1969.4 |
| Cohort 3 (6 Weeks GT1) | Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 4806.0 ng*h/mL | Standard Deviation 1945.4 |
| Cohort 3 (6 Weeks GT1) | Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 1187.3 ng*h/mL | Standard Deviation 600.9 |
| Cohort 3 (6 Weeks GT1) | Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 932.7 ng*h/mL | Standard Deviation 330.1 |
| Cohort 4 (12 Weeks GT1) | Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 1044.7 ng*h/mL | Standard Deviation 561.1 |
| Cohort 4 (12 Weeks GT1) | Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 1792.2 ng*h/mL | Standard Deviation 1350.9 |
| Cohort 4 (12 Weeks GT1) | Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 5425.2 ng*h/mL | Standard Deviation 1878.2 |
Secondary
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
AUC(0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 1049.3 nanogram*hours per milliliters (ng*h/mL) | Standard Deviation 890 |
| Cohort 1 (8 Weeks Genotype [GT1]) | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 2920.0 nanogram*hours per milliliters (ng*h/mL) | Standard Deviation 1029.1 |
| Cohort 1 (8 Weeks Genotype [GT1]) | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 469.3 nanogram*hours per milliliters (ng*h/mL) | Standard Deviation 224 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 660.7 nanogram*hours per milliliters (ng*h/mL) | Standard Deviation 211.5 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 1185.8 nanogram*hours per milliliters (ng*h/mL) | Standard Deviation 502.8 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 3238.2 nanogram*hours per milliliters (ng*h/mL) | Standard Deviation 972.8 |
| Cohort 2 (8 Weeks GT1) | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 1526.3 nanogram*hours per milliliters (ng*h/mL) | Standard Deviation 1328.9 |
| Cohort 2 (8 Weeks GT1) | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 5258.1 nanogram*hours per milliliters (ng*h/mL) | Standard Deviation 1969.4 |
| Cohort 2 (8 Weeks GT1) | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 945.2 nanogram*hours per milliliters (ng*h/mL) | Standard Deviation 551.1 |
| Cohort 3 (6 Weeks GT1) | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 5218.3 nanogram*hours per milliliters (ng*h/mL) | Standard Deviation 2011.9 |
| Cohort 3 (6 Weeks GT1) | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 1178.5 nanogram*hours per milliliters (ng*h/mL) | Standard Deviation 594 |
| Cohort 3 (6 Weeks GT1) | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 844.2 nanogram*hours per milliliters (ng*h/mL) | Standard Deviation 287.9 |
| Cohort 4 (12 Weeks GT1) | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 1774.8 nanogram*hours per milliliters (ng*h/mL) | Standard Deviation 1348.5 |
| Cohort 4 (12 Weeks GT1) | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 5425.2 nanogram*hours per milliliters (ng*h/mL) | Standard Deviation 1878.2 |
| Cohort 4 (12 Weeks GT1) | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 933.3 nanogram*hours per milliliters (ng*h/mL) | Standard Deviation 544.3 |
Secondary
AUC (0-24) for Odalasvir
AUC(0-24) is the area under the plasma concentration-time curve from time zero to time 24 hours for odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | AUC (0-24) for Odalasvir | 11805.5 ng*h/mL | Standard Deviation 4902.6 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | AUC (0-24) for Odalasvir | 5530.0 ng*h/mL | Standard Deviation 2930.3 |
| Cohort 2 (8 Weeks GT1) | AUC (0-24) for Odalasvir | 5393.8 ng*h/mL | Standard Deviation 2695.4 |
| Cohort 3 (6 Weeks GT1) | AUC (0-24) for Odalasvir | 4048.3 ng*h/mL | Standard Deviation 2727.8 |
| Cohort 4 (12 Weeks GT1) | AUC (0-24) for Odalasvir | 4924.1 ng*h/mL | Standard Deviation 2122.9 |
Secondary
AUC (0-24) of Simeprevir
AUC (0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | AUC (0-24) of Simeprevir | 25018.2 ng*h/ml | Standard Deviation 15248.7 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | AUC (0-24) of Simeprevir | 23061.3 ng*h/ml | Standard Deviation 24724.4 |
| Cohort 2 (8 Weeks GT1) | AUC (0-24) of Simeprevir | 25266.7 ng*h/ml | Standard Deviation 15523.4 |
| Cohort 3 (6 Weeks GT1) | AUC (0-24) of Simeprevir | 27070.7 ng*h/ml | Standard Deviation 15895.7 |
Secondary
AUC (0-last) of Odalasvir
AUC(0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | AUC (0-last) of Odalasvir | 11805.5 ng*h/ml | Standard Deviation 4902.6 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | AUC (0-last) of Odalasvir | 8635.5 ng*h/ml | Standard Deviation 4656.7 |
| Cohort 2 (8 Weeks GT1) | AUC (0-last) of Odalasvir | 8648.1 ng*h/ml | Standard Deviation 4161.1 |
| Cohort 3 (6 Weeks GT1) | AUC (0-last) of Odalasvir | 7050.0 ng*h/ml | Standard Deviation 4001.4 |
| Cohort 4 (12 Weeks GT1) | AUC (0-last) of Odalasvir | 8422.2 ng*h/ml | Standard Deviation 3617.8 |
Secondary
AUC (0-last) of Simeprevir
AUC (0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | AUC (0-last) of Simeprevir | 25018.2 ng*h/ml | Standard Deviation 15248.7 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | AUC (0-last) of Simeprevir | 23061.3 ng*h/ml | Standard Deviation 24724.4 |
| Cohort 2 (8 Weeks GT1) | AUC (0-last) of Simeprevir | 25266.7 ng*h/ml | Standard Deviation 15523.4 |
| Cohort 3 (6 Weeks GT1) | AUC (0-last) of Simeprevir | 27070.7 ng*h/ml | Standard Deviation 15895.7 |
Secondary
Average Plasma Concentration at Steady State (Css,Avg) of ALS-022227
Css,avg is the average plasma concentration at steady state of ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Average Plasma Concentration at Steady State (Css,Avg) of ALS-022227 | 121.49 ng/ml | Standard Deviation 42.81 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Average Plasma Concentration at Steady State (Css,Avg) of ALS-022227 | 135.20 ng/ml | Standard Deviation 41.16 |
| Cohort 2 (8 Weeks GT1) | Average Plasma Concentration at Steady State (Css,Avg) of ALS-022227 | 218.88 ng/ml | Standard Deviation 81.8 |
| Cohort 3 (6 Weeks GT1) | Average Plasma Concentration at Steady State (Css,Avg) of ALS-022227 | 217.17 ng/ml | Standard Deviation 83.26 |
| Cohort 4 (12 Weeks GT1) | Average Plasma Concentration at Steady State (Css,Avg) of ALS-022227 | 227.37 ng/ml | Standard Deviation 78.46 |
Secondary
Average Plasma Concentration at Steady State (Css,Avg) of Odalasvir
Css,avg is the average plasma concentration at steady state of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Average Plasma Concentration at Steady State (Css,Avg) of Odalasvir | 491.55 ng/ml | Standard Deviation 203.85 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Average Plasma Concentration at Steady State (Css,Avg) of Odalasvir | 181.60 ng/ml | Standard Deviation 97.99 |
| Cohort 2 (8 Weeks GT1) | Average Plasma Concentration at Steady State (Css,Avg) of Odalasvir | 181.58 ng/ml | Standard Deviation 87.25 |
| Cohort 3 (6 Weeks GT1) | Average Plasma Concentration at Steady State (Css,Avg) of Odalasvir | 147.40 ng/ml | Standard Deviation 83.86 |
| Cohort 4 (12 Weeks GT1) | Average Plasma Concentration at Steady State (Css,Avg) of Odalasvir | 176.86 ng/ml | Standard Deviation 75.91 |
Secondary
Average Plasma Concentration at Steady State (Css,Avg) of Simeprevir
Css,avg is the average plasma concentration at steady state of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Average Plasma Concentration at Steady State (Css,Avg) of Simeprevir | 1042.8 ng/ml | Standard Deviation 634.3 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Average Plasma Concentration at Steady State (Css,Avg) of Simeprevir | 960.5 ng/ml | Standard Deviation 1030.7 |
| Cohort 2 (8 Weeks GT1) | Average Plasma Concentration at Steady State (Css,Avg) of Simeprevir | 1053.8 ng/ml | Standard Deviation 647.8 |
| Cohort 3 (6 Weeks GT1) | Average Plasma Concentration at Steady State (Css,Avg) of Simeprevir | 1134.6 ng/ml | Standard Deviation 666.6 |
Secondary
Clast of Odalasvir
Clast is the last measurable plasma concentration (Clast) of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Clast of Odalasvir | 384.09 ng/ml | Standard Deviation 172.29 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Clast of Odalasvir | 162.65 ng/ml | Standard Deviation 87.39 |
| Cohort 2 (8 Weeks GT1) | Clast of Odalasvir | 163.54 ng/ml | Standard Deviation 78.1 |
| Cohort 3 (6 Weeks GT1) | Clast of Odalasvir | 131.92 ng/ml | Standard Deviation 74.01 |
| Cohort 4 (12 Weeks GT1) | Clast of Odalasvir | 152.47 ng/ml | Standard Deviation 66.5 |
Secondary
Clast of Simeprevir
Clast is the maximum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Clast of Simeprevir | 402.55 ng/ml | Standard Deviation 244.2 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Clast of Simeprevir | 481.76 ng/ml | Standard Deviation 644.76 |
| Cohort 2 (8 Weeks GT1) | Clast of Simeprevir | 538.67 ng/ml | Standard Deviation 456.21 |
| Cohort 3 (6 Weeks GT1) | Clast of Simeprevir | 602.60 ng/ml | Standard Deviation 453.12 |
Secondary
Cmax of Odalasvir
Cmax is the maximum observed plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Cmax of Odalasvir | 634.27 ng/ml | Standard Deviation 257.29 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Cmax of Odalasvir | 363.36 ng/ml | Standard Deviation 184.48 |
| Cohort 2 (8 Weeks GT1) | Cmax of Odalasvir | 322.46 ng/ml | Standard Deviation 167.29 |
| Cohort 3 (6 Weeks GT1) | Cmax of Odalasvir | 232.85 ng/ml | Standard Deviation 187.53 |
| Cohort 4 (12 Weeks GT1) | Cmax of Odalasvir | 298.67 ng/ml | Standard Deviation 133.99 |
Secondary
Cmax of Simeprevir
Cmax is the maximum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Cmax of Simeprevir | 1927.7 ng/ml | Standard Deviation 1205.3 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Cmax of Simeprevir | 1537.6 ng/ml | Standard Deviation 1325.2 |
| Cohort 2 (8 Weeks GT1) | Cmax of Simeprevir | 1769.3 ng/ml | Standard Deviation 881.6 |
| Cohort 3 (6 Weeks GT1) | Cmax of Simeprevir | 1925.1 ng/ml | Standard Deviation 1034 |
Secondary
Cmin of Odalasvir
Cmin is the minimum observed plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Cmin of Odalasvir | 322.45 ng/ml | Standard Deviation 139.21 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Cmin of Odalasvir | 97.21 ng/ml | Standard Deviation 58.62 |
| Cohort 2 (8 Weeks GT1) | Cmin of Odalasvir | 107.90 ng/ml | Standard Deviation 49.46 |
| Cohort 3 (6 Weeks GT1) | Cmin of Odalasvir | 102.73 ng/ml | Standard Deviation 47.08 |
| Cohort 4 (12 Weeks GT1) | Cmin of Odalasvir | 131.31 ng/ml | Standard Deviation 62.31 |
Secondary
Cmin of Simeprevir
Cmin is the minimum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Cmin of Simeprevir | 379.75 ng/ml | Standard Deviation 247.02 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Cmin of Simeprevir | 452.65 ng/ml | Standard Deviation 641.99 |
| Cohort 2 (8 Weeks GT1) | Cmin of Simeprevir | 517.00 ng/ml | Standard Deviation 416.45 |
| Cohort 3 (6 Weeks GT1) | Cmin of Simeprevir | 561.19 ng/ml | Standard Deviation 424.71 |
Secondary
Ctrough of Odalasvir
Ctrough is the trough plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Ctrough of Odalasvir | 335.18 ng/ml | Standard Deviation 146.14 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Ctrough of Odalasvir | 100.98 ng/ml | Standard Deviation 61.9 |
| Cohort 2 (8 Weeks GT1) | Ctrough of Odalasvir | 112.44 ng/ml | Standard Deviation 51.53 |
| Cohort 3 (6 Weeks GT1) | Ctrough of Odalasvir | 119.82 ng/ml | Standard Deviation 58.87 |
| Cohort 4 (12 Weeks GT1) | Ctrough of Odalasvir | 141.56 ng/ml | Standard Deviation 64.81 |
Secondary
Ctrough of Simeprevir
Ctrough is the trough plasma concentration of Simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Ctrough of Simeprevir | 475.42 ng/ml | Standard Deviation 317.63 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Ctrough of Simeprevir | 570.64 ng/ml | Standard Deviation 816.36 |
| Cohort 2 (8 Weeks GT1) | Ctrough of Simeprevir | 669.00 ng/ml | Standard Deviation 442.5 |
| Cohort 3 (6 Weeks GT1) | Ctrough of Simeprevir | 636.88 ng/ml | Standard Deviation 455.94 |
Secondary
Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227)
Clast is the last measurable plasma concentration (Clast) of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) | AL-335 | 5.931 ng/ml | Standard Deviation 4.752 |
| Cohort 1 (8 Weeks Genotype [GT1]) | Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) | ALS-022399 | 5.995 ng/ml | Standard Deviation 1.649 |
| Cohort 1 (8 Weeks Genotype [GT1]) | Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) | ALS-022227 | 38.28 ng/ml | Standard Deviation 12.2 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) | ALS-022227 | 47.26 ng/ml | Standard Deviation 10.68 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) | AL-335 | 7.077 ng/ml | Standard Deviation 4.676 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) | ALS-022399 | 10.335 ng/ml | Standard Deviation 5.558 |
| Cohort 2 (8 Weeks GT1) | Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) | ALS-022399 | 14.591 ng/ml | Standard Deviation 10.741 |
| Cohort 2 (8 Weeks GT1) | Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) | ALS-022227 | 67.08 ng/ml | Standard Deviation 40.66 |
| Cohort 2 (8 Weeks GT1) | Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) | AL-335 | 4.983 ng/ml | Standard Deviation 3.339 |
| Cohort 3 (6 Weeks GT1) | Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) | ALS-022399 | 14.793 ng/ml | Standard Deviation 8.738 |
| Cohort 3 (6 Weeks GT1) | Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) | AL-335 | 5.698 ng/ml | Standard Deviation 5.62 |
| Cohort 3 (6 Weeks GT1) | Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) | ALS-022227 | 69.18 ng/ml | Standard Deviation 38.01 |
| Cohort 4 (12 Weeks GT1) | Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) | AL-335 | 5.811 ng/ml | Standard Deviation 8.622 |
| Cohort 4 (12 Weeks GT1) | Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) | ALS-022227 | 72.14 ng/ml | Standard Deviation 29.23 |
| Cohort 4 (12 Weeks GT1) | Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227) | ALS-022399 | 17.520 ng/ml | Standard Deviation 10.972 |
Secondary
Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Cmax is the maximum observed plasma concentration of AL-335 and its metabolites (ALS-022227). For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 414.79 ng/mL | Standard Deviation 317.93 |
| Cohort 1 (8 Weeks Genotype [GT1]) | Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 364.4 ng/mL | Standard Deviation 129.1 |
| Cohort 1 (8 Weeks Genotype [GT1]) | Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 103.57 ng/mL | Standard Deviation 52.25 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 148.89 ng/mL | Standard Deviation 48.77 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 547.36 ng/mL | Standard Deviation 226.06 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 392.6 ng/mL | Standard Deviation 144.2 |
| Cohort 2 (8 Weeks GT1) | Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 174.89 ng/mL | Standard Deviation 87.05 |
| Cohort 2 (8 Weeks GT1) | Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 563.04 ng/mL | Standard Deviation 423.53 |
| Cohort 2 (8 Weeks GT1) | Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 658.0 ng/mL | Standard Deviation 275.1 |
| Cohort 3 (6 Weeks GT1) | Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 529.17 ng/mL | Standard Deviation 265.17 |
| Cohort 3 (6 Weeks GT1) | Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 643.2 ng/mL | Standard Deviation 318.4 |
| Cohort 3 (6 Weeks GT1) | Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 158.80 ng/mL | Standard Deviation 55.97 |
| Cohort 4 (12 Weeks GT1) | Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 186.28 ng/mL | Standard Deviation 113.18 |
| Cohort 4 (12 Weeks GT1) | Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 677.59 ng/mL | Standard Deviation 554.83 |
| Cohort 4 (12 Weeks GT1) | Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 619.7 ng/mL | Standard Deviation 224.1 |
Secondary
Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Cmin is the minimum observed plasma concentration of AL-335 and its metabolites (ALS-022399 and ALS-022227). For Pharmacokinetic (PK) analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 0.000 nanogram per milliliter (ng/ml) | Standard Deviation 0 |
| Cohort 1 (8 Weeks Genotype [GT1]) | Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 0.0 nanogram per milliliter (ng/ml) | Standard Deviation 0 |
| Cohort 1 (8 Weeks Genotype [GT1]) | Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 35.73 nanogram per milliliter (ng/ml) | Standard Deviation 13.61 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 0.0 nanogram per milliliter (ng/ml) | Standard Deviation 0 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 35.80 nanogram per milliliter (ng/ml) | Standard Deviation 11.15 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 0.000 nanogram per milliliter (ng/ml) | Standard Deviation 0 |
| Cohort 2 (8 Weeks GT1) | Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 0.0 nanogram per milliliter (ng/ml) | Standard Deviation 0 |
| Cohort 2 (8 Weeks GT1) | Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 0.308 nanogram per milliliter (ng/ml) | Standard Deviation 1.233 |
| Cohort 2 (8 Weeks GT1) | Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 57.25 nanogram per milliliter (ng/ml) | Standard Deviation 31.63 |
| Cohort 3 (6 Weeks GT1) | Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 68.30 nanogram per milliliter (ng/ml) | Standard Deviation 38.33 |
| Cohort 3 (6 Weeks GT1) | Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 0.0 nanogram per milliliter (ng/ml) | Standard Deviation 0 |
| Cohort 3 (6 Weeks GT1) | Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 0.000 nanogram per milliliter (ng/ml) | Standard Deviation 0 |
| Cohort 4 (12 Weeks GT1) | Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 0.280 nanogram per milliliter (ng/ml) | Standard Deviation 0.814 |
| Cohort 4 (12 Weeks GT1) | Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 0.0 nanogram per milliliter (ng/ml) | Standard Deviation 0 |
| Cohort 4 (12 Weeks GT1) | Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 64.96 nanogram per milliliter (ng/ml) | Standard Deviation 28.63 |
Secondary
Number of Participants With HCV Nonstructural Protein NS5A, NS5B, and NS3/4A Sequence in Participants With Virologic Failure
Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants with virologic failure.
Time frame: Up to Week 24 (Follow up visit)
Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Participants who had virologic failure were included in this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Number of Participants With HCV Nonstructural Protein NS5A, NS5B, and NS3/4A Sequence in Participants With Virologic Failure | 4 Participants |
| Cohort 4 (12 Weeks GT1) | Number of Participants With HCV Nonstructural Protein NS5A, NS5B, and NS3/4A Sequence in Participants With Virologic Failure | 1 Participants |
| Cohort 5a (8 Weeks GT3) | Number of Participants With HCV Nonstructural Protein NS5A, NS5B, and NS3/4A Sequence in Participants With Virologic Failure | 0 Participants |
| Cohort 5b (12 Weeks GT3) | Number of Participants With HCV Nonstructural Protein NS5A, NS5B, and NS3/4A Sequence in Participants With Virologic Failure | 2 Participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Number of Participants With HCV Nonstructural Protein NS5A, NS5B, and NS3/4A Sequence in Participants With Virologic Failure | 1 Participants |
Secondary
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Percentage of participants who achieved HCV RNA less then (\<) LLOQ undetectable was reported.
Time frame: Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 4 | 80.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | End of treatment | 95.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 11 | NA Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 7 | 90.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 2 | 0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 5 | 100 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 9 | NA Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 3 | 0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 2 | 35.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 6 | 90.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 12 | NA Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 3 | 70.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 1 | 5.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 10 | NA Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 8 | 95.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 3 | 0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 4 | 92.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 5 | 96.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 12 | NA Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 10 | NA Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 8 | 100 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 11 | NA Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 2 | 0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 9 | NA Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | End of treatment | 100 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 7 | 96.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 1 | 20.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 6 | 100 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 3 | 76.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 2 | 44.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 12 | NA Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 3 | 0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 2 | 0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 4 | 90.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 8 | 100 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 11 | NA Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 9 | NA Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 1 | 0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 2 | 45.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 6 | 85.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 5 | 100 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 3 | 75.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 7 | 95.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | End of treatment | 100 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 10 | NA Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 8 | NA Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 6 | 90.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 3 | 5.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 3 | 80.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 5 | 90.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | End of treatment | 90.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 10 | NA Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 4 | 85.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 11 | NA Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 7 | NA Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 12 | NA Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 2 | 0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 1 | 30.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 2 | 70.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 9 | NA Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 8 | 87.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 10 | 87.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 9 | 87.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | End of treatment | 87.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 2 | 0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 3 | 0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 1 | 12.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 2 | 25.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 12 | 87.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 3 | 62.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 4 | 87.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 5 | 100 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 6 | 100 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 11 | 87.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 7 | 100 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 9 | NA Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 11 | NA Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 3 | 60.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 12 | NA Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 6 | 100 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 2 | 40.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 3 | 0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 1 | 20.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 8 | 100 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 7 | 80.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 2 | 0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 10 | NA Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 4 | 60.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | End of treatment | 100 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 5 | 80.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 3 | 0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 5 | 92.9 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 3 | 85.7 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 11 | 92.9 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 7 | 85.7 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 4 | 92.9 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 2 | 0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | End of treatment | 85.7 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 2 | 64.3 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 9 | 92.9 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 1 | 35.7 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 6 | 92.9 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 10 | 92.9 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 8 | 85.7 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 12 | 85.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 3 | 0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 1 | 16.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 10 | NA Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 2 | 0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 2 | 50.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 3 | 73.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 4 | 80.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 5 | 90.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 6 | 96.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 7 | 100 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 8 | 100 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 9 | NA Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 11 | NA Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 12 | NA Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | End of treatment | 100 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 8 | 93.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 7 | 100 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 6 | 100 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 5 | 100 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 11 | 86.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 4 | 86.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 3 | 86.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 2 | 66.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | End of treatment | 93.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 12 | 93.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 3 | 6.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 2 | 0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 10 | 93.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 1 | 13.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 9 | 93.3 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 8 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 7 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 3 | 0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 6 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 10 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 5 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 9 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | End of treatment | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 12 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 11 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 4 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 1 | 25.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 3 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Day 2 | 0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable | Week 2 | 75.0 Percentage of participants |
Secondary
Percentage of Participants Who Achieved HCV RNA <LLOQ
Percentage of participants who achieved HCV RNA \<LLOQ was reported.
Time frame: Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 12 | NA Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 8 | 85.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 11 | NA Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 3 | 0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 2 | 20.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 7 | 80.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 2 | 0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA <LLOQ | End of treatment | 85.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 4 | 55.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 9 | NA Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 3 | 40.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 1 | 0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 6 | 80.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 5 | 75.0 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 10 | NA Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 11 | NA Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 2 | 0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 3 | 0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 3 | 40.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 2 | 20.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 12 | NA Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 8 | 96.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 6 | 88.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 10 | NA Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 4 | 52.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 7 | 92.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 5 | 96.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 9 | NA Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | End of treatment | 96.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 1 | 8.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 4 | 60.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 5 | 85.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 7 | 95.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 12 | NA Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 8 | 100 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 10 | NA Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | End of treatment | 100 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 11 | NA Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 2 | 0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 3 | 0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 9 | NA Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 1 | 0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 2 | 15.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 3 | 45.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 6 | 85.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 5 | 85.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 2 | 0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 1 | 10.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 11 | NA Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 10 | NA Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 8 | NA Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 12 | NA Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 2 | 40.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | End of treatment | 80.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 3 | 65.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 7 | NA Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 6 | 80.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 4 | 80.0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 3 | 0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 9 | NA Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 2 | 0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 6 | 87.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 3 | 0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 5 | 75.0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | End of treatment | 87.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 1 | 0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 7 | 87.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 11 | 87.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 10 | 87.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 4 | 62.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 8 | 87.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 2 | 0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 3 | 37.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 12 | 87.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 9 | 87.5 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 2 | 0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 2 | 20.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 7 | 80.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 10 | NA Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 3 | 0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 1 | 0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 3 | 60.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 4 | 40.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 5 | 80.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 6 | 80.0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 8 | 100 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 9 | NA Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 11 | NA Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 12 | NA Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | End of treatment | 100 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 8 | 85.7 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 12 | 78.6 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 9 | 92.9 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 1 | 14.3 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 5 | 85.7 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 3 | 50.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | End of treatment | 78.6 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 2 | 42.9 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 6 | 92.9 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 4 | 78.6 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 7 | 85.7 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 11 | 92.9 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 10 | 92.9 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 2 | 0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 3 | 0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 7 | 100 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 3 | 73.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 6 | 96.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 8 | 100 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 1 | 16.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 3 | 0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 9 | NA Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 10 | NA Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | End of treatment | 100 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 2 | 0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 11 | NA Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 12 | NA Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 4 | 80.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 2 | 50.0 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 5 | 90.0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 5 | 100 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 6 | 100 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 2 | 66.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | End of treatment | 93.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 3 | 86.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 1 | 13.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 11 | 86.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 3 | 0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 10 | 93.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 2 | 0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 8 | 93.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 12 | 93.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 9 | 93.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 4 | 86.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 7 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 2 | 0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 10 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | End of treatment | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 4 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 1 | 25.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 6 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 5 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 11 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 7 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 2 | 75.0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 8 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Day 3 | 0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 3 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 9 | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants Who Achieved HCV RNA <LLOQ | Week 12 | 100 Percentage of participants |
Secondary
Percentage of Participants With On-treatment Failure
On-treatment failure was defined by participants who did not achieve SVR12 and with confirmed HCV RNA \>= LLOQ at the actual end of study drug treatment.
Time frame: Up to 12 weeks
Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With On-treatment Failure | 0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With On-treatment Failure | 0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With On-treatment Failure | 0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With On-treatment Failure | 0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With On-treatment Failure | 12.5 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With On-treatment Failure | 0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With On-treatment Failure | 7.1 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With On-treatment Failure | 0 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With On-treatment Failure | 0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With On-treatment Failure | 0 Percentage of participants |
Secondary
Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment
Participants were considered to have achieved SVR if the Hepatitis C virus (HCV) Ribonucleic acid (RNA) less than (\<) Lower limit of quantification (LLOQ) (\<15 international unit per milliliter \[IU/mL\]) detectable or undetectable at Week 4, 12 and 24 after the actual end of study drug treatment.
Time frame: At Week 4, 12 and Week 24 after end of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 4 weeks after end of treatment | 100 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 24 weeks after end of treatment | 100 Percentage of participants |
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 12 weeks after end of treatment | 100 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 12 weeks after end of treatment | 84.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 24 weeks after end of treatment | 84.0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 4 weeks after end of treatment | 96.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 24 weeks after end of treatment | 100 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 4 weeks after end of treatment | 100 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 12 weeks after end of treatment | 100 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 24 weeks after end of treatment | 100 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 4 weeks after end of treatment | 100 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 12 weeks after end of treatment | 100 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 4 weeks after end of treatment | 87.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 12 weeks after end of treatment | 87.5 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 24 weeks after end of treatment | 87.5 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 12 weeks after end of treatment | 0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 4 weeks after end of treatment | 0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 24 weeks after end of treatment | 0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 4 weeks after end of treatment | 71.4 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 24 weeks after end of treatment | 71.4 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 12 weeks after end of treatment | 71.4 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 12 weeks after end of treatment | 96.7 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 4 weeks after end of treatment | 100 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 24 weeks after end of treatment | 96.7 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 12 weeks after end of treatment | 93.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 4 weeks after end of treatment | 93.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 24 weeks after end of treatment | 93.3 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 4 weeks after end of treatment | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 24 weeks after end of treatment | 100 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment | 12 weeks after end of treatment | 100 Percentage of participants |
Secondary
Percentage of Participants With Virologic Relapse During the Follow-up Period
Viral relapse is defined as participants SVR12, with HCV RNA \<LLOQ at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (\>=) LLOQ during follow up.
Time frame: Follow up period (Up to Week 12 after end of treatment)
Population: Safety set included all participants enrolled into study who had received at least 1 dose of any study drug, whether prematurely withdrawn from study or not.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Percentage of Participants With Virologic Relapse During the Follow-up Period | 0 Percentage of participants |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Percentage of Participants With Virologic Relapse During the Follow-up Period | 16.0 Percentage of participants |
| Cohort 2 (8 Weeks GT1) | Percentage of Participants With Virologic Relapse During the Follow-up Period | 0 Percentage of participants |
| Cohort 3 (6 Weeks GT1) | Percentage of Participants With Virologic Relapse During the Follow-up Period | 0 Percentage of participants |
| Cohort 4 (12 Weeks GT1) | Percentage of Participants With Virologic Relapse During the Follow-up Period | 0 Percentage of participants |
| Cohort 5a (8 Weeks GT3) | Percentage of Participants With Virologic Relapse During the Follow-up Period | 100.0 Percentage of participants |
| Cohort 5b (12 Weeks GT3) | Percentage of Participants With Virologic Relapse During the Follow-up Period | 14.3 Percentage of participants |
| Cohort 6,7,8 (8 Weeks GT1 F4) | Percentage of Participants With Virologic Relapse During the Follow-up Period | 3.3 Percentage of participants |
| Cohort 9 (12 Weeks GT1 F4) | Percentage of Participants With Virologic Relapse During the Follow-up Period | 0 Percentage of participants |
| Cohort 11 (12 Weeks GT2 F4) | Percentage of Participants With Virologic Relapse During the Follow-up Period | 0 Percentage of participants |
Secondary
Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Tlast is the time corresponding to last measurable plasma concentration for AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 12.000 Hours |
| Cohort 1 (8 Weeks Genotype [GT1]) | Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 24.00 Hours |
| Cohort 1 (8 Weeks Genotype [GT1]) | Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 6.000 Hours |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 24.00 Hours |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 6.000 Hours |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 12.000 Hours |
| Cohort 2 (8 Weeks GT1) | Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 24.00 Hours |
| Cohort 2 (8 Weeks GT1) | Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 6.000 Hours |
| Cohort 2 (8 Weeks GT1) | Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 12.000 Hours |
| Cohort 3 (6 Weeks GT1) | Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 6.025 Hours |
| Cohort 3 (6 Weeks GT1) | Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 12.000 Hours |
| Cohort 3 (6 Weeks GT1) | Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 24.00 Hours |
| Cohort 4 (12 Weeks GT1) | Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 12.000 Hours |
| Cohort 4 (12 Weeks GT1) | Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 23.90 Hours |
| Cohort 4 (12 Weeks GT1) | Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 8.670 Hours |
Secondary
Time to Achieve Undetectable HCV RNA or < LLOQ HCV RNA
Time to achieve undetectable HCV RNA or \< LLOQ HCV RNA was reported.
Time frame: Up to Week 24 (follow up visit)
Population: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Data was not collected and analyzed for this outcome measure as per the change in planned analysis.
Secondary
Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Tmax is the time to reach the maximum plasma concentration of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 2.000 Hours |
| Cohort 1 (8 Weeks Genotype [GT1]) | Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 4.000 Hours |
| Cohort 1 (8 Weeks Genotype [GT1]) | Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 3.0 Hours |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 3.000 Hours |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 2.000 Hours |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 4.000 Hours |
| Cohort 2 (8 Weeks GT1) | Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 3.000 Hours |
| Cohort 2 (8 Weeks GT1) | Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 1.500 Hours |
| Cohort 2 (8 Weeks GT1) | Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 3.500 Hours |
| Cohort 3 (6 Weeks GT1) | Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 1.000 Hours |
| Cohort 3 (6 Weeks GT1) | Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 3.500 Hours |
| Cohort 3 (6 Weeks GT1) | Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 2.000 Hours |
| Cohort 4 (12 Weeks GT1) | Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 3.000 Hours |
| Cohort 4 (12 Weeks GT1) | Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | 2.000 Hours |
| Cohort 4 (12 Weeks GT1) | Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 4.000 Hours |
Secondary
Tlast of Odalasvir
Tlast is the time corresponding to last measurable plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Tlast of Odalasvir | 24.00 Hours |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Tlast of Odalasvir | 47.60 Hours |
| Cohort 2 (8 Weeks GT1) | Tlast of Odalasvir | 47.50 Hours |
| Cohort 3 (6 Weeks GT1) | Tlast of Odalasvir | 47.80 Hours |
| Cohort 4 (12 Weeks GT1) | Tlast of Odalasvir | 47.50 Hours |
Secondary
Tlast of Simeprevir
Tlast is the time corresponding to last measurable plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Tlast of Simeprevir | 24.00 Hours |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Tlast of Simeprevir | 24.00 Hours |
| Cohort 2 (8 Weeks GT1) | Tlast of Simeprevir | 24.00 Hours |
| Cohort 3 (6 Weeks GT1) | Tlast of Simeprevir | 23.90 Hours |
Secondary
Tmax of Odalasvir
Tmax is the time to reach the maximum plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Tmax of Odalasvir | 6.000 Hours |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Tmax of Odalasvir | 6.000 Hours |
| Cohort 2 (8 Weeks GT1) | Tmax of Odalasvir | 6.000 Hours |
| Cohort 3 (6 Weeks GT1) | Tmax of Odalasvir | 4.500 Hours |
| Cohort 4 (12 Weeks GT1) | Tmax of Odalasvir | 6.000 Hours |
Secondary
Tmax of Simeprevir
Tmax is the Time to reach the maximum plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Tmax of Simeprevir | 6.000 Hours |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Tmax of Simeprevir | 6.000 Hours |
| Cohort 2 (8 Weeks GT1) | Tmax of Simeprevir | 6.000 Hours |
| Cohort 3 (6 Weeks GT1) | Tmax of Simeprevir | 6.000 Hours |
Secondary
Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Ctrough is the trough plasma concentration for AL-335 and its metabolites (ALS-022399 and ALS-022227). For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Population: PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis. Here, 'n' signifies the number of participants analyzed for specified analyte.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (8 Weeks Genotype [GT1]) | Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 42.74 ng/ml | Standard Deviation 19.26 |
| Cohort 1b + Cohort 4 (8 Weeks GT1) | Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 36.77 ng/ml | Standard Deviation 10.42 |
| Cohort 2 (8 Weeks GT1) | Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 4.640 ng/ml | Standard Deviation 4.018 |
| Cohort 2 (8 Weeks GT1) | Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 61.82 ng/ml | Standard Deviation 35.47 |
| Cohort 3 (6 Weeks GT1) | Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 4.570 ng/ml | Standard Deviation 2.899 |
| Cohort 3 (6 Weeks GT1) | Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 86.20 ng/ml | Standard Deviation 56.31 |
| Cohort 4 (12 Weeks GT1) | Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022399 | 4.400 ng/ml | Standard Deviation 2.56 |
| Cohort 4 (12 Weeks GT1) | Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | ALS-022227 | 73.85 ng/ml | Standard Deviation 35.15 |
| Unknown | Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227) | AL-335 | — ng/ml | — |