Epilepsy
Conditions
Keywords
Epilepsy, Idiopathic Generalized Epilepsy, Absence Seizures
Brief summary
This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period after the last dose of study medication.
Detailed description
This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period after the last dose of study medication. Subjects will participate for a total of up to 9 weeks, including screening, the 4-week treatment period and follow-up.
Interventions
DRUGCX-8998
T-type calcium channel blocker
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent form (ICF) indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. 2. Men or non-pregnant, non-breastfeeding women 16 to 55 years-of-age who are able to read and understand written and spoken local language. 3. Clinical diagnosis of IGE (including, but not limited to, CAE, JAE, juvenile myoclonic epilepsy, or Jeavons syndrome) with absence seizures consistent with the International League against Epilepsy Revised Classification of Seizures (2017). 4. Absence seizures persisting despite standard of care (SOC) treatment, defined as treatment with at least 2 AEDs appropriate for the patient's epilepsy syndrome. SOC failure, per investigator discretion, will be defined as insufficient clinical response or intolerable side effects, which precludes use of the appropriate AED. 5. Observation of at least 3 instances of generalized discharges of approximately 2.5 - 4 Hz lasting ≥2 seconds via 24-hour ambulatory EEG (centrally reviewed), with approximately 75% normal background based on age and medication use per the central EEG reader's discretion. Intermittent focal spikes are allowed. 6. On stable doses of one or more antiepileptic medication(s) for at least 30 days. If a subject is not on medication, adequate documentation justifying lack of therapy may be acceptable for the subject after sponsor review. Ketogenic, modified Atkins diet (MAD), or low glycemic diet with stable carbohydrate ratio for at least 30 days before screening is an acceptable antiepileptic therapy. Vagal nerve stimulation at stable settings (for at least 30 days before screening), without use of the magnet, is also acceptable. 7. Body weight ≥ 45 kg at screening. 8. Subjects with reproductive capability including all males and women of child-bearing potential (WOCBP) must agree to practice continuous abstinence or adequate contraception methods (appropriate double barrier method or oral, patch, implant, or injectable contraception) from as soon as feasible during screening period until at least 30 days after the last dose (i.e., intermittent abstinence based on rhythm, temperature monitoring, or other means of timing is not acceptable). WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, and/or bilateral oophorectomy) or is not post-menopausal. Post-menopausal is defined as amenorrhea ≥ 12 consecutive months without another cause, and a documented serum follicle stimulating hormone (FSH) level ≥ 35 mIU/mL. 9. Male subjects with a partner of child-bearing potential must be surgically sterilized or be willing to use condoms with spermicide from as soon as feasible during screening period until at least 30 days after the last dose. 10. Able and willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 11. Approval by the sponsor medical personnel or delegate as to final eligibility for the study.
Exclusion criteria
1. History of surgical intervention for treatment of epilepsy. 2. Additional seizure (clinical and electrographic) types, including, but not limited to, epileptic spasms, generalized tonic seizures, atonic seizures, or focal seizures. Subjects with GTCS or myoclonic seizures are eligible for the study. 3. Inadequately treated psychotic or mood disorder (e.g., schizophrenia, major depression, bipolar disorder). 4. Presence of severe intellectual disability, severe autism spectrum disorder, or severe developmental disorder such that the subject cannot sign the ICF or cannot cooperate with the study procedures. 5. Presence of positive urine drug screen for drugs of abuse, except if this is explained by use of an allowed prescription medicine. 6. Regular use of more than 2 standard drinks of alcohol per day (28 grams of pure alcohol). 7. Hypersensitivity/allergic reaction to other T-type calcium agents, such as (but not limited to) ethosuximide and zonisamide. 8. Use of strong CYP3A4 inhibitors, including prescription or non-prescription drugs or other products (i.e. grapefruit juice), which cannot be discontinued at least 2 weeks prior to Day 1 of dosing and throughout the study (Appendix C). 9. Concurrent illnesses that would be a contraindication to trial participation, including, but not limited to: 1. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before screening 2. NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled hypertension 3. Clinically significant ECG abnormality per the Investigator assessment or any of the following: i) QTcF ≥450 msec (males) or ≥470 msec (females) ii) PR interval ≥250 msec iii) Atrioventricular block of second degree or higher, including Mobitz I iv) Persistent sinus bradycardia ≤ 50 beats per minute; persistent means the bradycardia is present on the first ECG and on one repeat ECG performed on another day v) For other ECG findings (e.g., including, but not necessarily limited to, tachycardia, bundle branch block, frequent ectopic beats, etc.) the Investigator should send a scanned, identity-blinded copy of the ECG tracing to the Study Safety Representative for review. 10. Positive result for HIV, Hepatitis B \[indicating ongoing infection\], or Hepatitis C at screening or otherwise known ongoing infection with HIV, hepatitis B, or hepatitis C, unless curative therapy completed; for hepatitis C curative therapy is defined as negative PCR for HCV RNA. 11. Significant hepatic (AST/ALT or bilirubin ≥ 2X upper limit of normal) or renal disease (creatinine clearance ≤39 mL/min) at screening. 12. History of alcohol or substance abuse within the last year. 13. A current C-SSRS score of 4 or 5 at screening or history of suicide attempt. 14. Psychological, social, familial, or geographical reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process. 15. Any other condition and/or situation that causes the Investigator or Study Safety Representative to deem a subject unsuitable for the study (including, but not limited to, expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures). 16. Treatment with an investigational agent within 30 days prior to the first dose of CX-8998 or planning to receive an investigational agent during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to End of Treatment in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. | Fridericia's Correction Formula (QTCF) is a formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates. |
| Change From Baseline to End of Treatment in Clinical Alanine Aminotransferase Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in alanine aminotransferase serum chemistry concentration. |
| Change From Baseline to End of Treatment in Clinical Albumin Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in albumin serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Albumin/Globulin Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in albumin/globulin serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Alkaline Phosphatase Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in alkaline phosphatase serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Aspartate Aminotransferase Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in aspartate aminotransferase serum chemistry. |
| Baseline Clinical Blood Urea Nitrogen/Creatinine Serum Chemistry Concentration | Baseline (Day 1) | Clinical safety laboratory assessment in BUN/Creatinine serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Bilirubin Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in bilirubin serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Blood Urea Nitrogen Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in blood urea nitrogen serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Carbon Dioxide Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in carbon dioxide serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Chloride Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in chloride serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Calcium Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in calcium serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Cholesterol Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in cholesterol serum chemistry. |
| Baseline Clinical Cholesterol/HDL-Cholesterol Serum Chemistry Concentration | Baseline (Day 1) | Clinical safety laboratory assessment in cholesterol/HDL-cholesterol serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Creatine Kinase Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in creatine kinase serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Creatinine Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in creatinine serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Globulin Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in globulin serum chemistry. |
| Baseline Clinical Glomerular Filtration Rate (GFR) Adjusted for Body Surface Area (BSA) Serum Chemistry Concentration | Baseline (Day 1) | Clinical safety laboratory assessment in glomerular filtration rate adjusted for BSA chemistry. |
| Change From Baseline to End of Treatment in Clinical Estimated Glomerular Filtration Rate (GFR) Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in GFR serum chemistry. |
| Baseline Clinical Non-HDL Cholesterol Serum Chemistry Concentration | Baseline (Day 1) | Clinical safety laboratory assessment in non-HDL cholesterol serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Glucose Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in glucose serum chemistry. |
| Baseline Clinical HDL Cholesterol Serum Chemistry Concentration | Baseline (Day 1) | Clinical safety laboratory assessment in HDL cholesterol serum chemistry. |
| Baseline Clinical LDL Cholesterol Serum Chemistry Concentration | Baseline (Day 1) | Clinical safety laboratory assessment in LDL cholesterol serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Lactate Dehydrogenase Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in lactate dehydrogenase serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Magnesium Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in magnesium serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Phosphate Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in phosphate serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Potassium Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in potassium serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Protein Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in protein serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Sodium Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in sodium serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Triglycerides Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in triglycerides serum chemistry. |
| Change From Baseline to End of Treatment in Clinical Urate Serum Chemistry Concentration | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory assessment in urate serum chemistry. |
| Change From Baseline to End of Treatment in Basophils Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory basophils hematology assessment. |
| Change From Baseline to End of Treatment in Basophils/Leukocytes Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory basophils/leukocytes hematology assessment. |
| Change From Baseline to End of Treatment in Eosinophils Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory eosinophils hematology assessment. |
| Change From Baseline to End of Treatment in Eosinophils/Leukocytes Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory eosinophils/leukocytes hematology assessment. |
| Change From Baseline to End of Treatment in Mean Corpuscular Hemoglobin (HGB) Concentration Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory mean corpuscular HGB concentration hematology assessment. |
| Change From Baseline to End of Treatment in Mean Corpuscular Hemoglobin (HGB) Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory mean corpuscular HGB hematology assessment. |
| Change From Baseline to End of Treatment in Mean Corpuscular Volume Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory mean corpuscular volume hematology assessment. |
| Change From Baseline to End of Treatment in Erythrocytes Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory erythrocytes hematology assessment. |
| Change From Baseline to End of Treatment in Erythrocytes Distribution Width Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory erythrocytes distribution width hematology assessment. |
| Change From Baseline to End of Treatment in Hematocrit Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory hematocrit hematology assessment. |
| Change From Baseline to End of Treatment in Hemaglobin Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory hemaglobin hematology assessment. |
| Change From Baseline to End of Treatment in Leukocytes Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory leukocytes hematology assessment. |
| Change From Baseline to End of Treatment in Lymphocytes Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory lymphocytes hematology assessment. |
| Change From Baseline to End of Treatment in Lymphocytes/Leukocytes Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory lymphocytes/leukocytes hematology assessment. |
| Change From Baseline to End of Treatment in Mean Platelet Volume Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory mean platelet volume hematology assessment. |
| Change From Baseline to End of Treatment in Monocytes Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory monocytes hematology assessment. |
| Baseline to End of Treatment in Bacteria Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory bacteria urinalysis assessment. |
| Baseline to End of Treatment in Urine Bilirubin Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory urine bilirubin urinalysis assessment. |
| Change From Baseline to End of Treatment in Monocytes/Leukocytes Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory monocytes/leukocytes hematology assessment. |
| Change From Baseline to End of Treatment in Neutrophils Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory neutrophils hematology assessment. |
| Change From Baseline to End of Treatment in Neutrophils/Leukocytes Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory neutrophils/leukocytes hematology assessment. |
| Change From Baseline to End of Treatment in Platelets Hematology Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory platelets hematology assessment. |
| Baseline to End of Treatment in Epithelial Cells Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory epithelial cells urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-10 epithelial cells/high power field (hpf). A worse outcome is \>10 epithelial cells. |
| Baseline to End of Treatment in Urine Erythrocytes Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory urine erythrocytes urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-2 erythrocytes/high power field (hpf). A better outcome is 0 or none seen. |
| Baseline to End of Treatment in Urine Glucose Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory urine glucose urinalysis assessment. |
| Baseline to End of Treatment in Ketones Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory ketones urinalysis assessment. |
| Baseline to End of Treatment in Leukocyte Esterase Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory leukocyte esterase urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is negative. An abnormal assessment or worse outcome is a positive assessment (i.e., 2+). |
| Baseline to End of Treatment in Urine Leukocytes Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory urine leukocytes urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-5 leukocytes/high power field (hpf). An abnormal assessment or worse outcome is \>5 leukocytes/hpf (i.e., 11-30). |
| Baseline to End of Treatment in Mucous Threads Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory mucous threads urinalysis assessment. |
| Baseline to End of Treatment in Nitrite Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory nitrite urinalysis assessment. |
| Baseline to End of Treatment in Occult Blood Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory occult blood urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is negative. An abnormal assessment or worse outcome is a positive assessment (i.e., 2+). |
| Baseline to End of Treatment in Protein Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory protein urinalysis assessment. |
| Baseline to End of Treatment in Specific Gravity Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory specific gravity urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is 1.005-1.030. An abnormal assessment or worse outcome is a value outside of this range. |
| Baseline to End of Treatment in Specimen Appearance Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory specimen appearance urinalysis assessment. |
| Change From Baseline to End of Treatment in Urobilinogen Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory urobilinogen urinalysis assessment. |
| Baseline to End of Treatment in pH Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory pH urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. |
| Baseline to End of Treatment in Urine Color Urinalysis Assessment | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. | Clinical safety laboratory urine color urinalysis assessment. |
| Number (%) of Participants Who Did Not Complete The Study Due to Treatment-Emergent Adverse Events | Baseline (Day 1) up to Day 26 post-dose, or up to 1 year 3 weeks. | Treatment-emergent adverse events are all adverse events occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period as assessed by CTCAE v4.0. |
| Number (%) of Participants With Adverse Events of Special Interest | Baseline (Day 1) up to Day 26 post-dose, or up to 1 year 3 weeks. | An adverse event of special interest is a serious adverse event as defined in Outcome 6. This includes, however is not limited to, increased seizure frequency, new seizure types, worsening of EEG parameters, systemic adverse events based on safety profile as assessed by CTCAE v4.0. |
| Change From Baseline to End of Treatment in Respiration Rate | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. | — |
| Change From Baseline to End of Treatment in Temperature | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. | — |
| Baseline Weight | Baseline (Day 1) | — |
| Change From Baseline to End of Treatment in Pulse | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. | The change from baseline to end of treatment in participants' pulses was assessed. The changes in recumbent pulse, standing pulse, and the change from recumbent to standing pulse are reported. Change from recumbent to standing pulse was measured by the difference in recumbent pulse change and standing pulse change. |
| Change From Baseline to End of Treatment in Systolic Blood Pressure | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. | The change from baseline to end of treatment in participants' systolic blood pressure (sbp) was assessed. The changes in recumbent sbp, standing sbp, and the change from recumbent to standing sbp are reported. Change from recumbent to standing sbp was measured by the difference in recumbent sbp change and standing sbp change. |
| Change From Baseline to End of Treatment in Diastolic Blood Pressure | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. | The change from baseline to end of treatment in participants' diastolic blood pressure (dbp) was assessed. The changes in recumbent dbp, standing dbp, and the change from recumbent to standing dbp are reported. Change from recumbent to standing dbp was measured by the difference in recumbent dbp change and standing dbp change. |
| Change From Baseline to End of Treatment in QT Interval | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. | — |
| Change From Baseline to End of Treatment in QRS Interval | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. | — |
| Change From Baseline to End of Treatment in PR Interval | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. | — |
| Change From Baseline to End of Treatment in Heart Rate | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. | — |
Countries
United States
Participant flow
Pre-assignment details
Participants underwent a screening period of up to 4 weeks.
Participants by arm
| Arm | Count |
|---|---|
| CX-8998 Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d). | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Missed Day 27 Dosing | 1 |
Baseline characteristics
| Characteristic | CX-8998 |
|---|---|
| Age, Continuous | 31.3 years STANDARD_DEVIATION 8.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 3 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 2 / 7 | 2 / 5 | 0 / 6 | 1 / 6 | 2 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Baseline Clinical Blood Urea Nitrogen/Creatinine Serum Chemistry Concentration
Clinical safety laboratory assessment in BUN/Creatinine serum chemistry.
Time frame: Baseline (Day 1)
Population: Clinical BUN/Creatinine serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CX-8998 | Baseline Clinical Blood Urea Nitrogen/Creatinine Serum Chemistry Concentration | 12.70 ratio |
Primary
Baseline Clinical Cholesterol/HDL-Cholesterol Serum Chemistry Concentration
Clinical safety laboratory assessment in cholesterol/HDL-cholesterol serum chemistry.
Time frame: Baseline (Day 1)
Population: Clinical cholesterol/HDL-cholesterol serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CX-8998 | Baseline Clinical Cholesterol/HDL-Cholesterol Serum Chemistry Concentration | 2.40 ratio |
Primary
Baseline Clinical Glomerular Filtration Rate (GFR) Adjusted for Body Surface Area (BSA) Serum Chemistry Concentration
Clinical safety laboratory assessment in glomerular filtration rate adjusted for BSA chemistry.
Time frame: Baseline (Day 1)
Population: The clinical glomerular filtration rate adjusted for BSA serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CX-8998 | Baseline Clinical Glomerular Filtration Rate (GFR) Adjusted for Body Surface Area (BSA) Serum Chemistry Concentration | 1.80 mL/sec/1.73m^2 |
Primary
Baseline Clinical HDL Cholesterol Serum Chemistry Concentration
Clinical safety laboratory assessment in HDL cholesterol serum chemistry.
Time frame: Baseline (Day 1)
Population: Clinical HDL-cholesterol serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CX-8998 | Baseline Clinical HDL Cholesterol Serum Chemistry Concentration | 1.35 nmol/L |
Primary
Baseline Clinical LDL Cholesterol Serum Chemistry Concentration
Clinical safety laboratory assessment in LDL cholesterol serum chemistry.
Time frame: Baseline (Day 1)
Population: Clinical LDL-cholesterol serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CX-8998 | Baseline Clinical LDL Cholesterol Serum Chemistry Concentration | 1.50 nmol/L |
Primary
Baseline Clinical Non-HDL Cholesterol Serum Chemistry Concentration
Clinical safety laboratory assessment in non-HDL cholesterol serum chemistry.
Time frame: Baseline (Day 1)
Population: Clinical LDL-cholesterol serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CX-8998 | Baseline Clinical Non-HDL Cholesterol Serum Chemistry Concentration | 1.84 nmol/L |
Primary
Baseline to End of Treatment in Bacteria Urinalysis Assessment
Clinical safety laboratory bacteria urinalysis assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Bacteria urinalysis was assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Baseline to End of Treatment in Bacteria Urinalysis Assessment | Baseline (Not seen) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in Bacteria Urinalysis Assessment | End of Treatment (Few) | 1 Participants |
Primary
Baseline to End of Treatment in Epithelial Cells Urinalysis Assessment
Clinical safety laboratory epithelial cells urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-10 epithelial cells/high power field (hpf). A worse outcome is \>10 epithelial cells.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Epithelial cells were assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Baseline to End of Treatment in Epithelial Cells Urinalysis Assessment | Baseline (0-10) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in Epithelial Cells Urinalysis Assessment | End of Treatment (>10) | 1 Participants |
Primary
Baseline to End of Treatment in Ketones Urinalysis Assessment
Clinical safety laboratory ketones urinalysis assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Ketones were assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Baseline to End of Treatment in Ketones Urinalysis Assessment | Baseline (Negative) | 3 Participants |
| CX-8998 | Baseline to End of Treatment in Ketones Urinalysis Assessment | Baseline (Trace) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in Ketones Urinalysis Assessment | End of Treatment (Negative) | 2 Participants |
Primary
Baseline to End of Treatment in Leukocyte Esterase Urinalysis Assessment
Clinical safety laboratory leukocyte esterase urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is negative. An abnormal assessment or worse outcome is a positive assessment (i.e., 2+).
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Leukocyte esterase was assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Baseline to End of Treatment in Leukocyte Esterase Urinalysis Assessment | Baseline (Negative) | 4 Participants |
| CX-8998 | Baseline to End of Treatment in Leukocyte Esterase Urinalysis Assessment | End of Treatment (2+) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in Leukocyte Esterase Urinalysis Assessment | End of Treatment (Negative) | 1 Participants |
Primary
Baseline to End of Treatment in Mucous Threads Urinalysis Assessment
Clinical safety laboratory mucous threads urinalysis assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Mucous threads were assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Baseline to End of Treatment in Mucous Threads Urinalysis Assessment | Baseline (Present) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in Mucous Threads Urinalysis Assessment | End of Treatment (Present) | 1 Participants |
Primary
Baseline to End of Treatment in Nitrite Urinalysis Assessment
Clinical safety laboratory nitrite urinalysis assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Nitrite was assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Baseline to End of Treatment in Nitrite Urinalysis Assessment | Baseline (Negative) | 4 Participants |
| CX-8998 | Baseline to End of Treatment in Nitrite Urinalysis Assessment | End of Treatment (Negative) | 2 Participants |
Primary
Baseline to End of Treatment in Occult Blood Urinalysis Assessment
Clinical safety laboratory occult blood urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is negative. An abnormal assessment or worse outcome is a positive assessment (i.e., 2+).
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Occult blood was assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Baseline to End of Treatment in Occult Blood Urinalysis Assessment | Baseline (2+) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in Occult Blood Urinalysis Assessment | Baseline (Negative) | 3 Participants |
| CX-8998 | Baseline to End of Treatment in Occult Blood Urinalysis Assessment | End of Treatment (Negative) | 2 Participants |
Primary
Baseline to End of Treatment in pH Urinalysis Assessment
Clinical safety laboratory pH urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: pH was assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Baseline to End of Treatment in pH Urinalysis Assessment | Baseline (5) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in pH Urinalysis Assessment | Baseline (6) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in pH Urinalysis Assessment | Baseline (6.6) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in pH Urinalysis Assessment | Baseline (7) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in pH Urinalysis Assessment | End of Treatment (5) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in pH Urinalysis Assessment | End of Treatment (5.5) | 2 Participants |
Primary
Baseline to End of Treatment in Protein Urinalysis Assessment
Clinical safety laboratory protein urinalysis assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Protein was assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Baseline to End of Treatment in Protein Urinalysis Assessment | Baseline (Negative) | 4 Participants |
| CX-8998 | Baseline to End of Treatment in Protein Urinalysis Assessment | End of Treatment (Negative) | 2 Participants |
Primary
Baseline to End of Treatment in Specific Gravity Urinalysis Assessment
Clinical safety laboratory specific gravity urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is 1.005-1.030. An abnormal assessment or worse outcome is a value outside of this range.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Specific gravity was assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Baseline to End of Treatment in Specific Gravity Urinalysis Assessment | Baseline (1.015) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in Specific Gravity Urinalysis Assessment | Baseline (1.019) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in Specific Gravity Urinalysis Assessment | Baseline (1.025) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in Specific Gravity Urinalysis Assessment | Baseline (1.029) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in Specific Gravity Urinalysis Assessment | End of Treatment (1.023) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in Specific Gravity Urinalysis Assessment | End of Treatment (1.024) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in Specific Gravity Urinalysis Assessment | End of Treatment (1.026) | 1 Participants |
Primary
Baseline to End of Treatment in Specimen Appearance Urinalysis Assessment
Clinical safety laboratory specimen appearance urinalysis assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Specimen appearance was assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Baseline to End of Treatment in Specimen Appearance Urinalysis Assessment | Baseline (Clear) | 4 Participants |
| CX-8998 | Baseline to End of Treatment in Specimen Appearance Urinalysis Assessment | End of Treatment (Clear) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in Specimen Appearance Urinalysis Assessment | End of Treatment (Cloudy) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in Specimen Appearance Urinalysis Assessment | End of Treatment (Turbid) | 1 Participants |
Primary
Baseline to End of Treatment in Urine Bilirubin Urinalysis Assessment
Clinical safety laboratory urine bilirubin urinalysis assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Urine bilirubin was assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Baseline to End of Treatment in Urine Bilirubin Urinalysis Assessment | Baseline (Negative) | 4 Participants |
| CX-8998 | Baseline to End of Treatment in Urine Bilirubin Urinalysis Assessment | End of Treatment (Negative) | 2 Participants |
Primary
Baseline to End of Treatment in Urine Color Urinalysis Assessment
Clinical safety laboratory urine color urinalysis assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Urine color was assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Baseline to End of Treatment in Urine Color Urinalysis Assessment | Baseline (Yellow) | 4 Participants |
| CX-8998 | Baseline to End of Treatment in Urine Color Urinalysis Assessment | End of Treatment (Yellow) | 2 Participants |
Primary
Baseline to End of Treatment in Urine Erythrocytes Urinalysis Assessment
Clinical safety laboratory urine erythrocytes urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-2 erythrocytes/high power field (hpf). A better outcome is 0 or none seen.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Urine erythrocytes were assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Baseline to End of Treatment in Urine Erythrocytes Urinalysis Assessment | Baseline (0-2) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in Urine Erythrocytes Urinalysis Assessment | End of Treatment (None seen) | 1 Participants |
Primary
Baseline to End of Treatment in Urine Glucose Urinalysis Assessment
Clinical safety laboratory urine glucose urinalysis assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Urine glucose were assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Baseline to End of Treatment in Urine Glucose Urinalysis Assessment | Baseline (Negative) | 4 Participants |
| CX-8998 | Baseline to End of Treatment in Urine Glucose Urinalysis Assessment | End of Treatment (Negative) | 2 Participants |
Primary
Baseline to End of Treatment in Urine Leukocytes Urinalysis Assessment
Clinical safety laboratory urine leukocytes urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-5 leukocytes/high power field (hpf). An abnormal assessment or worse outcome is \>5 leukocytes/hpf (i.e., 11-30).
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Urine leukocytes were assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Baseline to End of Treatment in Urine Leukocytes Urinalysis Assessment | Baseline (0-5) | 1 Participants |
| CX-8998 | Baseline to End of Treatment in Urine Leukocytes Urinalysis Assessment | End of Treatment (11-30) | 1 Participants |
Primary
Baseline Weight
Time frame: Baseline (Day 1)
Population: Weight was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Baseline Weight | 82.19 kg | Standard Deviation 15.963 |
Primary
Change From Baseline to End of Treatment in Basophils Hematology Assessment
Clinical safety laboratory basophils hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical basophils were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Basophils Hematology Assessment | 0.02 cellsx10E9/L | Standard Deviation 0.029 |
Primary
Change From Baseline to End of Treatment in Basophils/Leukocytes Hematology Assessment
Clinical safety laboratory basophils/leukocytes hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical basophils/leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Basophils/Leukocytes Hematology Assessment | 0.00 ratio | Standard Deviation 0.004 |
Primary
Change From Baseline to End of Treatment in Clinical Alanine Aminotransferase Serum Chemistry Concentration
Clinical safety laboratory assessment in alanine aminotransferase serum chemistry concentration.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical alanine aminotransferase serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Alanine Aminotransferase Serum Chemistry Concentration | 17.29 U/L | Standard Deviation 33.604 |
Primary
Change From Baseline to End of Treatment in Clinical Albumin/Globulin Serum Chemistry Concentration
Clinical safety laboratory assessment in albumin/globulin serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical albumin/globulin serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Albumin/Globulin Serum Chemistry Concentration | -0.15 ratio | Standard Deviation 0.212 |
Primary
Change From Baseline to End of Treatment in Clinical Albumin Serum Chemistry Concentration
Clinical safety laboratory assessment in albumin serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical albumin serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Albumin Serum Chemistry Concentration | -0.29 g/L | Standard Deviation 4.152 |
Primary
Change From Baseline to End of Treatment in Clinical Alkaline Phosphatase Serum Chemistry Concentration
Clinical safety laboratory assessment in alkaline phosphatase serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical alkaline phosphatase serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Alkaline Phosphatase Serum Chemistry Concentration | 3.14 U/L | Standard Deviation 10.399 |
Primary
Change From Baseline to End of Treatment in Clinical Aspartate Aminotransferase Serum Chemistry Concentration
Clinical safety laboratory assessment in aspartate aminotransferase serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical aspartate aminotransferase serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Aspartate Aminotransferase Serum Chemistry Concentration | 27.71 U/L | Standard Deviation 60.81 |
Primary
Change From Baseline to End of Treatment in Clinical Bilirubin Serum Chemistry Concentration
Clinical safety laboratory assessment in bilirubin serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical bilirubin serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Bilirubin Serum Chemistry Concentration | -0.55 umol/L | Standard Deviation 2.577 |
Primary
Change From Baseline to End of Treatment in Clinical Blood Urea Nitrogen Serum Chemistry Concentration
Clinical safety laboratory assessment in blood urea nitrogen serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical blood urea nitrogen serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Blood Urea Nitrogen Serum Chemistry Concentration | 0.23 umol/L | Standard Deviation 1.254 |
Primary
Change From Baseline to End of Treatment in Clinical Calcium Serum Chemistry Concentration
Clinical safety laboratory assessment in calcium serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical calcium serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Calcium Serum Chemistry Concentration | -0.01 nmol/L | Standard Deviation 0.109 |
Primary
Change From Baseline to End of Treatment in Clinical Carbon Dioxide Serum Chemistry Concentration
Clinical safety laboratory assessment in carbon dioxide serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical carbon dioxide serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Carbon Dioxide Serum Chemistry Concentration | 0.43 nmol/L | Standard Deviation 2.936 |
Primary
Change From Baseline to End of Treatment in Clinical Chloride Serum Chemistry Concentration
Clinical safety laboratory assessment in chloride serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical chloride serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Chloride Serum Chemistry Concentration | -0.86 nmol/L | Standard Deviation 3.716 |
Primary
Change From Baseline to End of Treatment in Clinical Cholesterol Serum Chemistry Concentration
Clinical safety laboratory assessment in cholesterol serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical cholesterol serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Cholesterol Serum Chemistry Concentration | 0.60 nmol/L | Standard Deviation 0.895 |
Primary
Change From Baseline to End of Treatment in Clinical Creatine Kinase Serum Chemistry Concentration
Clinical safety laboratory assessment in creatine kinase serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical creatine kinase serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Creatine Kinase Serum Chemistry Concentration | 1174.86 U/L | Standard Deviation 3110.151 |
Primary
Change From Baseline to End of Treatment in Clinical Creatinine Serum Chemistry Concentration
Clinical safety laboratory assessment in creatinine serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical creatinine serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Creatinine Serum Chemistry Concentration | -4.14 umol/L | Standard Deviation 9.737 |
Primary
Change From Baseline to End of Treatment in Clinical Estimated Glomerular Filtration Rate (GFR) Serum Chemistry Concentration
Clinical safety laboratory assessment in GFR serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical GFR serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Estimated Glomerular Filtration Rate (GFR) Serum Chemistry Concentration | -5.82 mL/sec/1.73m^2 | Standard Deviation 9.691 |
Primary
Change From Baseline to End of Treatment in Clinical Globulin Serum Chemistry Concentration
Clinical safety laboratory assessment in globulin serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical globulin serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Globulin Serum Chemistry Concentration | 0.15 g/dL | Standard Deviation 0.071 |
Primary
Change From Baseline to End of Treatment in Clinical Glucose Serum Chemistry Concentration
Clinical safety laboratory assessment in glucose serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical glucose serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Glucose Serum Chemistry Concentration | -0.14 nmol/L | Standard Deviation 0.526 |
Primary
Change From Baseline to End of Treatment in Clinical Lactate Dehydrogenase Serum Chemistry Concentration
Clinical safety laboratory assessment in lactate dehydrogenase serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical lactate dehydrogenase serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Lactate Dehydrogenase Serum Chemistry Concentration | 53.86 U/L | Standard Deviation 98.104 |
Primary
Change From Baseline to End of Treatment in Clinical Magnesium Serum Chemistry Concentration
Clinical safety laboratory assessment in magnesium serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical magnesium serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Magnesium Serum Chemistry Concentration | -0.02 nmol/L | Standard Deviation 0.077 |
Primary
Change From Baseline to End of Treatment in Clinical Phosphate Serum Chemistry Concentration
Clinical safety laboratory assessment in phosphate serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical phosphate serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Phosphate Serum Chemistry Concentration | 0.09 nmol/L | Standard Deviation 0.163 |
Primary
Change From Baseline to End of Treatment in Clinical Potassium Serum Chemistry Concentration
Clinical safety laboratory assessment in potassium serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical potassium serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Potassium Serum Chemistry Concentration | 0.34 nmol/L | Standard Deviation 0.532 |
Primary
Change From Baseline to End of Treatment in Clinical Protein Serum Chemistry Concentration
Clinical safety laboratory assessment in protein serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical protein serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Protein Serum Chemistry Concentration | 0.29 g/L | Standard Deviation 3.352 |
Primary
Change From Baseline to End of Treatment in Clinical Sodium Serum Chemistry Concentration
Clinical safety laboratory assessment in sodium serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical sodium serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Sodium Serum Chemistry Concentration | -0.57 nmol/L | Standard Deviation 1.902 |
Primary
Change From Baseline to End of Treatment in Clinical Triglycerides Serum Chemistry Concentration
Clinical safety laboratory assessment in triglycerides serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical triglycerides serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Triglycerides Serum Chemistry Concentration | 0.17 nmol/L | Standard Deviation 0.659 |
Primary
Change From Baseline to End of Treatment in Clinical Urate Serum Chemistry Concentration
Clinical safety laboratory assessment in urate serum chemistry.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical urate serum chemistry was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Clinical Urate Serum Chemistry Concentration | 8.71 umol/L | Standard Deviation 48.555 |
Primary
Change From Baseline to End of Treatment in Diastolic Blood Pressure
The change from baseline to end of treatment in participants' diastolic blood pressure (dbp) was assessed. The changes in recumbent dbp, standing dbp, and the change from recumbent to standing dbp are reported. Change from recumbent to standing dbp was measured by the difference in recumbent dbp change and standing dbp change.
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Population: Diastolic blood pressure was assessed using the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Diastolic Blood Pressure | Recumbent | -8.14 mmHg | Standard Deviation 14.916 |
| CX-8998 | Change From Baseline to End of Treatment in Diastolic Blood Pressure | Standing | 1.86 mmHg | Standard Deviation 7.267 |
| CX-8998 | Change From Baseline to End of Treatment in Diastolic Blood Pressure | Change from Recumbent to Standing | 10.00 mmHg | Standard Deviation 8.737 |
Primary
Change From Baseline to End of Treatment in Eosinophils Hematology Assessment
Clinical safety laboratory eosinophils hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical eosinophils were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Eosinophils Hematology Assessment | 0.02 cellsx10E9/L | Standard Deviation 0.042 |
Primary
Change From Baseline to End of Treatment in Eosinophils/Leukocytes Hematology Assessment
Clinical safety laboratory eosinophils/leukocytes hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical eosinophils/leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Eosinophils/Leukocytes Hematology Assessment | 0.00 ratio | Standard Deviation 0.007 |
Primary
Change From Baseline to End of Treatment in Erythrocytes Distribution Width Hematology Assessment
Clinical safety laboratory erythrocytes distribution width hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical erythrocytes distribution width was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Erythrocytes Distribution Width Hematology Assessment | 0.00 ratio | Standard Deviation 0 |
Primary
Change From Baseline to End of Treatment in Erythrocytes Hematology Assessment
Clinical safety laboratory erythrocytes hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical erythrocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Erythrocytes Hematology Assessment | -0.02 cellsx10E12/L | Standard Deviation 0.194 |
Primary
Change From Baseline to End of Treatment in Heart Rate
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Population: Heart rate was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Heart Rate | 3.67 beats/min | Standard Deviation 13.866 |
Primary
Change From Baseline to End of Treatment in Hemaglobin Hematology Assessment
Clinical safety laboratory hemaglobin hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical hemoglobin was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Hemaglobin Hematology Assessment | 1.17 g/L | Standard Deviation 6.555 |
Primary
Change From Baseline to End of Treatment in Hematocrit Hematology Assessment
Clinical safety laboratory hematocrit hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical hematocrit was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Hematocrit Hematology Assessment | 0.00 ratio | Standard Deviation 0.015 |
Primary
Change From Baseline to End of Treatment in Leukocytes Hematology Assessment
Clinical safety laboratory leukocytes hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Leukocytes Hematology Assessment | 0.25 cellsx10E9/L | Standard Deviation 2.228 |
Primary
Change From Baseline to End of Treatment in Lymphocytes Hematology Assessment
Clinical safety laboratory lymphocytes hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Lymphocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Lymphocytes Hematology Assessment | -0.17 cellsx10E9/L | Standard Deviation 0.452 |
Primary
Change From Baseline to End of Treatment in Lymphocytes/Leukocytes Hematology Assessment
Clinical safety laboratory lymphocytes/leukocytes hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Lymphocytes/leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Lymphocytes/Leukocytes Hematology Assessment | -0.02 ratio | Standard Deviation 0.045 |
Primary
Change From Baseline to End of Treatment in Mean Corpuscular Hemoglobin (HGB) Concentration Hematology Assessment
Clinical safety laboratory mean corpuscular HGB concentration hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical mean corpuscular HGB concentration was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Mean Corpuscular Hemoglobin (HGB) Concentration Hematology Assessment | 0.00 nmol/L | Standard Deviation 1.23 |
Primary
Change From Baseline to End of Treatment in Mean Corpuscular Hemoglobin (HGB) Hematology Assessment
Clinical safety laboratory mean corpuscular HGB hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical mean corpuscular HGB was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Mean Corpuscular Hemoglobin (HGB) Hematology Assessment | -0.04 fmol | Standard Deviation 0.049 |
Primary
Change From Baseline to End of Treatment in Mean Corpuscular Volume Hematology Assessment
Clinical safety laboratory mean corpuscular volume hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Clinical mean corpuscular volume was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Mean Corpuscular Volume Hematology Assessment | -1.00 fL | Standard Deviation 2.828 |
Primary
Change From Baseline to End of Treatment in Mean Platelet Volume Hematology Assessment
Clinical safety laboratory mean platelet volume hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Mean platelet volume was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Mean Platelet Volume Hematology Assessment | 0.65 fL | Standard Deviation 1.202 |
Primary
Change From Baseline to End of Treatment in Monocytes Hematology Assessment
Clinical safety laboratory monocytes hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Monocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Monocytes Hematology Assessment | 0.01 cellsx10E9/L | Standard Deviation 0.067 |
Primary
Change From Baseline to End of Treatment in Monocytes/Leukocytes Hematology Assessment
Clinical safety laboratory monocytes/leukocytes hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Monocytes/leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Monocytes/Leukocytes Hematology Assessment | 0.00 ratio | Standard Deviation 0.021 |
Primary
Change From Baseline to End of Treatment in Neutrophils Hematology Assessment
Clinical safety laboratory neutrophils hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Neutrophils were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Neutrophils Hematology Assessment | 0.41 cellsx10E9/L | Standard Deviation 1.911 |
Primary
Change From Baseline to End of Treatment in Neutrophils/Leukocytes Hematology Assessment
Clinical safety laboratory neutrophils/leukocytes hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Neutrophils/leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Neutrophils/Leukocytes Hematology Assessment | 0.02 ratio | Standard Deviation 0.063 |
Primary
Change From Baseline to End of Treatment in Platelets Hematology Assessment
Clinical safety laboratory platelets hematology assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Platelets were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Platelets Hematology Assessment | 10.67 cellsx10E9/L | Standard Deviation 38.645 |
Primary
Change From Baseline to End of Treatment in PR Interval
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Population: PR interval was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in PR Interval | -0.17 msec | Standard Deviation 7.026 |
Primary
Change From Baseline to End of Treatment in Pulse
The change from baseline to end of treatment in participants' pulses was assessed. The changes in recumbent pulse, standing pulse, and the change from recumbent to standing pulse are reported. Change from recumbent to standing pulse was measured by the difference in recumbent pulse change and standing pulse change.
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Population: Pulse was assessed using the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Pulse | Recumbent | -9.71 bpm | Standard Deviation 8.036 |
| CX-8998 | Change From Baseline to End of Treatment in Pulse | Standing | -5.57 bpm | Standard Deviation 6.973 |
| CX-8998 | Change From Baseline to End of Treatment in Pulse | Change from Recumbent to Standing | 4.14 bpm | Standard Deviation 5.956 |
Primary
Change From Baseline to End of Treatment in QRS Interval
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Population: QRS interval was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in QRS Interval | -1.50 msec | Standard Deviation 2.811 |
Primary
Change From Baseline to End of Treatment in QT Interval
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Population: QT was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in QT Interval | -2.67 msec | Standard Deviation 12.801 |
Primary
Change From Baseline to End of Treatment in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Fridericia's Correction Formula (QTCF) is a formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates.
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Population: QTcF was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) | 3.50 msec | Standard Deviation 10.213 |
Primary
Change From Baseline to End of Treatment in Respiration Rate
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Population: Respiration rate was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Respiration Rate | 0.29 breaths/min | Standard Deviation 1.38 |
Primary
Change From Baseline to End of Treatment in Systolic Blood Pressure
The change from baseline to end of treatment in participants' systolic blood pressure (sbp) was assessed. The changes in recumbent sbp, standing sbp, and the change from recumbent to standing sbp are reported. Change from recumbent to standing sbp was measured by the difference in recumbent sbp change and standing sbp change.
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Population: Systolic blood pressure was assessed using the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Systolic Blood Pressure | Recumbent | -3.29 mmHg | Standard Deviation 14.338 |
| CX-8998 | Change From Baseline to End of Treatment in Systolic Blood Pressure | Standing | -2.86 mmHg | Standard Deviation 12.103 |
| CX-8998 | Change From Baseline to End of Treatment in Systolic Blood Pressure | Change from Recumbent to Standing | 0.43 mmHg | Standard Deviation 4.962 |
Primary
Change From Baseline to End of Treatment in Temperature
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Population: Temperature was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Temperature | -0.01 celsius | Standard Deviation 0.43 |
Primary
Change From Baseline to End of Treatment in Urobilinogen Urinalysis Assessment
Clinical safety laboratory urobilinogen urinalysis assessment.
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Population: Urobilinogen was assessed using the safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX-8998 | Change From Baseline to End of Treatment in Urobilinogen Urinalysis Assessment | 0.00 nmol/L | Standard Deviation 0 |
Primary
Number (%) of Participants Who Did Not Complete The Study Due to Treatment-Emergent Adverse Events
Treatment-emergent adverse events are all adverse events occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period as assessed by CTCAE v4.0.
Time frame: Baseline (Day 1) up to Day 26 post-dose, or up to 1 year 3 weeks.
Population: Participants who did not complete the study was assessed using the safety population. The number of participants analyzed varied as participation declined over time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CX-8998 | Number (%) of Participants Who Did Not Complete The Study Due to Treatment-Emergent Adverse Events | 0 Participants |
| CX-8998 Days 3 - 8 (8 mg/d) | Number (%) of Participants Who Did Not Complete The Study Due to Treatment-Emergent Adverse Events | 0 Participants |
| CX-8998 Days 9 - 14 (12 mg/d) | Number (%) of Participants Who Did Not Complete The Study Due to Treatment-Emergent Adverse Events | 0 Participants |
| CX-8998 Days 15 - 20 (16 mg/d) | Number (%) of Participants Who Did Not Complete The Study Due to Treatment-Emergent Adverse Events | 0 Participants |
| CX-8998 Days 21 - 27 (20 mg/d) | Number (%) of Participants Who Did Not Complete The Study Due to Treatment-Emergent Adverse Events | 0 Participants |
Primary
Number (%) of Participants With Adverse Events of Special Interest
An adverse event of special interest is a serious adverse event as defined in Outcome 6. This includes, however is not limited to, increased seizure frequency, new seizure types, worsening of EEG parameters, systemic adverse events based on safety profile as assessed by CTCAE v4.0.
Time frame: Baseline (Day 1) up to Day 26 post-dose, or up to 1 year 3 weeks.
Population: Participants with adverse events of special interest were assessed using the safety population. The number of participants analyzed varied as participation declined over time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CX-8998 | Number (%) of Participants With Adverse Events of Special Interest | Any Event | 1 Participants |
| CX-8998 | Number (%) of Participants With Adverse Events of Special Interest | Seizure | 1 Participants |
| CX-8998 Days 3 - 8 (8 mg/d) | Number (%) of Participants With Adverse Events of Special Interest | Any Event | 0 Participants |
| CX-8998 Days 3 - 8 (8 mg/d) | Number (%) of Participants With Adverse Events of Special Interest | Seizure | 0 Participants |
| CX-8998 Days 9 - 14 (12 mg/d) | Number (%) of Participants With Adverse Events of Special Interest | Any Event | 0 Participants |
| CX-8998 Days 9 - 14 (12 mg/d) | Number (%) of Participants With Adverse Events of Special Interest | Seizure | 0 Participants |
| CX-8998 Days 15 - 20 (16 mg/d) | Number (%) of Participants With Adverse Events of Special Interest | Seizure | 0 Participants |
| CX-8998 Days 15 - 20 (16 mg/d) | Number (%) of Participants With Adverse Events of Special Interest | Any Event | 0 Participants |
| CX-8998 Days 21 - 27 (20 mg/d) | Number (%) of Participants With Adverse Events of Special Interest | Any Event | 1 Participants |
| CX-8998 Days 21 - 27 (20 mg/d) | Number (%) of Participants With Adverse Events of Special Interest | Seizure | 1 Participants |