Infection, Human Immunodeficiency Virus, HIV Infections
Conditions
Keywords
Tuberculosis, Human Immunodeficiency Virus, Rifabutin, Drug-drug interaction, Cabotegravir
Brief summary
This is a Phase I, single-center, open-label, fixed-sequence, 2-period crossover study in healthy adults to evaluate the effect of oral rifabutin (RBT) 300 milligram (mg) on the pharmacokinetics of oral cabotegravir (CAB) 30 milligram ( mg). This study will evaluate the drug-drug interaction (DDI) potential between CAB and RBT to inform dosing strategies for tuberculosis in subjects receiving CAB for human immunodeficiency virus (HIV) treatment or prevention. In Treatment Period 1 (Treatment A) participants will receive CAB 30 mg once daily for 14 days, followed by Treatment Period 2 (Treatment B) where participants will receive RBT 300 mg once daily with CAB 30 mg once daily for 14 days. The total study duration will be approximately for 10 weeks. Approximately 15 healthy subjects will be enrolled to ensure that 12 subjects complete dosing and critical assessments.
Interventions
DRUGCabotegravir
It will be available as a white aquarius film coated tablet for oral administration. CAB Tablet is composed of GSK1265744B (micronized) lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate
DRUGRifabutin
It will be available as an opaque red-brown hard gelatin capsules containing 150 mg of rifabutin for oral administration. These capsules are composed of rifabutin, microcrystalline cellulose, sodium lauryl sulphate, magnesium stearate, and silica gel
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a 2-period crossover study in healthy adults
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Exclusion criteria
, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Additionally, laboratory assessments that are specifically listed in the inclusion or
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Plasma CAB Pharmacokinetic (PK) Parameter: Area Under the Concentration-time Curve Over One Dosing Interval (AUC [0 to Tau]) | Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28 | Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. AUC (0 to tau) was calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. PK Summary Population included participants who had CAB PK parameter estimates from both serial PK sampling time periods 1 and 2. Comparisons were made for the repeated dose PK parameters of CAB when given alone in Period 1 and when co-administered with steady-state RBT in Period 2. |
| Assessment of Plasma CAB PK Parameter: Maximum Observed Concentration (Cmax) | Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28 | Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. Cmax was determined directly from the concentration-time data. Comparisons were made for the repeated dose PK parameters of CAB when given alone in Period 1 and when co-administered with steady-state RBT in Period 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Plasma CAB PK Parameter: Terminal Phase Half-life (t1/2) | Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28 | Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. Apparent terminal half-life was calculated as: t1/2 = ln2 / Lambda\_z, where Lambda\_z is the terminal phase rate constant. Plasma t1/2 was not estimated for either period due to limited PK sampling in the terminal phase. |
| Assessment of Plasma CAB PK Parameter: The Apparent Oral Clearance (CL/F) | Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28 | Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. CL/F was calculated as CL/F =Dose/AUC(0 to tau). |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 10 weeks | An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect and associated with liver injury and impaired liver function. Safety Population comprised of all participants who enrolled in the study and received at least one dose of study drug. |
| Concurrent Medication Assessment in Treatment Period 1 and 2 | Up to 10 weeks | Concurrent medications included paracetamol and ibuprofen. Number of participants who took concurrent medications during the study are presented. |
| Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose) | Blood samples for hematology assessment were collected for basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose) | Blood samples for hematology assessment were collected for Hematocrit and R/E. NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Assessment of Hematology Parameter: Hemoglobin | Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose) | Blood samples for hematology assessment was collected for Hemoglobin. NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin | Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose) | Blood samples for hematology assessment was collected for Eryrocyte Mean Corpuscular Hemoglobin. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume | Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose) | Blood samples for hematology assessment was collected for Erythrocyte Mean Corpuscular Volume. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Assessment of Plasma CAB PK Parameter: Concentration at the End of the Dosing Interval (Ctau) | Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28 | Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. Comparisons were made for the repeated dose PK parameters of CAB when given alone in Period 1 and when co-administered with steady-state RBT in Period 2. |
| Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW) | Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose) | Blood samples for hematology assessment was collected for EDW. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Assessment of Clinical Chemistry Parameters: Albumin and Protein | Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose) | Samples for clinical chemistry assessment were collected for Albumin and Protein. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose) | Samples for clinical chemistry assessment were collected for ALP, AST, ALT, CK and GGT. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose) | Samples for clinical chemistry assessment were collected for DB, bilirubin and creatinine. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose) | Samples for clinical chemistry assessment were collected for Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Number of Participants With Abnormal Urinalysis Result | Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose) | Samples for urinalysis assessment was collected at Day -1, Day 13, Day 21, Day 27 and during follow-up period (10 to 14 daya after last dose). Data for participants with abnormal urinalysis results has been presented. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 1, 14, 21, 28 and follow-up (10 to 14 days after last dose) | ECG measurements was performed with the participant in a semi-supine position having rested in this position for at least 10 minutes beforehand. Data has been presented for Period 1, Day 14 pre-dose which showed abnormal- not clinically significant ECG finding. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline to follow-up (10 to 14 days after last dose) | Vital signs measurement was done in semi-supine position after 10 minutes rest and included SBP and DBP. Two blood pressure measurement were taken at pre-dose on Day 1, at least 1 minute apart. The mean value recorded at pre-dose was classified as Baseline. Single blood pressure was obtained at all other time points during the study. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Pulse Rate | Baseline to follow-up (10 to 14 days after last dose) | Vital signs measurement was done in semi-supine position after 10 minutes rest and included pulse rate. Two pulse rate measurement were taken at pre-dose on Day 1, at least 1 minute apart. The mean value recorded at pre-dose was classified as Baseline. Single pulse rate was obtained at all other time points during the study. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose) | Blood samples for hematology assessment were collected for Erythrocytes and reticulocytes. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Assessment of Plasma CAB PK Parameter: Time of Occurrence of Cmax (Tmax) | Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28 | Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. Tmax was determined directly from the concentration-time data. |
Countries
United Kingdom
Participant flow
Recruitment details
A total of 15 participants were enrolled from one center in the United Kingdom. The study was conducted from 06 June 2017 to 07 September 2017.
Pre-assignment details
A total of 26 participants were screened for the study. Of these, 6 participants did not meet the inclusion/exclusion criteria and 5 participants (reserved participants) were eligible however they did not participate in the study. Therefore, 15 participants were enrolled and received at least one dose of study medication.
Participants by arm
| Arm | Count |
|---|---|
| CAB 30 mg Followed by RBT 300 mg + CAB 30 mg Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Period 1 (Day 1 to Day 14) | Protocol-Defined Stopping criteria | 1 |
| Period 2 (Day 15 to Day 28) | Adverse Event | 2 |
Baseline characteristics
| Characteristic | CAB 30 mg Followed by RBT 300 mg + CAB 30 mg |
|---|---|
| Age, Continuous | 43.7 Years STANDARD_DEVIATION 10.51 |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 1 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European | 14 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 |
| other Total, other adverse events | 1 / 15 | 7 / 14 |
| serious Total, serious adverse events | 0 / 15 | 1 / 14 |
Outcome results
Primary
Assessment of Plasma CAB Pharmacokinetic (PK) Parameter: Area Under the Concentration-time Curve Over One Dosing Interval (AUC [0 to Tau])
Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. AUC (0 to tau) was calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. PK Summary Population included participants who had CAB PK parameter estimates from both serial PK sampling time periods 1 and 2. Comparisons were made for the repeated dose PK parameters of CAB when given alone in Period 1 and when co-administered with steady-state RBT in Period 2.
Time frame: Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28
Population: PK Summary Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB 30 mg | Assessment of Plasma CAB Pharmacokinetic (PK) Parameter: Area Under the Concentration-time Curve Over One Dosing Interval (AUC [0 to Tau]) | 103.978 Microgram * hour per milliliter | Geometric Coefficient of Variation 28.3 |
| RBT 300 mg + CAB 30 mg | Assessment of Plasma CAB Pharmacokinetic (PK) Parameter: Area Under the Concentration-time Curve Over One Dosing Interval (AUC [0 to Tau]) | 81.715 Microgram * hour per milliliter | Geometric Coefficient of Variation 29.9 |
90% CI: [0.743, 0.831]
Primary
Assessment of Plasma CAB PK Parameter: Maximum Observed Concentration (Cmax)
Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. Cmax was determined directly from the concentration-time data. Comparisons were made for the repeated dose PK parameters of CAB when given alone in Period 1 and when co-administered with steady-state RBT in Period 2.
Time frame: Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28
Population: PK Summary Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB 30 mg | Assessment of Plasma CAB PK Parameter: Maximum Observed Concentration (Cmax) | 6.356 Micrograms per milliliter | Geometric Coefficient of Variation 24.7 |
| RBT 300 mg + CAB 30 mg | Assessment of Plasma CAB PK Parameter: Maximum Observed Concentration (Cmax) | 5.246 Micrograms per milliliter | Geometric Coefficient of Variation 24.3 |
90% CI: [0.761, 0.895]
Secondary
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Samples for clinical chemistry assessment were collected for Albumin and Protein. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Albumin and Protein | Albumin, Day -1, n=15 | 45.2 Grams per Liter | Standard Deviation 1.9 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Albumin and Protein | Albumin, On-treatment, Period 1 Day 13, n=14 | 44.2 Grams per Liter | Standard Deviation 2.58 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Albumin and Protein | Albumin, On-treatment, Period 2 Day 21, n=13 | 43.4 Grams per Liter | Standard Deviation 2.06 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Albumin and Protein | Albumin, On-treatment, Period 2 Day 27, n=12 | 43.7 Grams per Liter | Standard Deviation 1.87 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Albumin and Protein | Albumin, Follow-up, Period 1 Day 13, n=1 | 38.0 Grams per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Albumin and Protein | Albumin, Follow-up, Period 2 Day 21, n=1 | 44.0 Grams per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Albumin and Protein | Albumin, Follow-up, Period 2 Day 27, n=1 | 42.0 Grams per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Albumin and Protein | Albumin, Follow-up, n=15 | 42.7 Grams per Liter | Standard Deviation 1.59 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Albumin and Protein | Protein, Day -1, n=15 | 67.9 Grams per Liter | Standard Deviation 3.98 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Albumin and Protein | Protein, On-treatment, Period 1 Day 13, n=14 | 67.3 Grams per Liter | Standard Deviation 3.22 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Albumin and Protein | Protein, On-treatment, Period 2 Day 21, n=13 | 65.1 Grams per Liter | Standard Deviation 3.82 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Albumin and Protein | Protein, On-treatment, Period 2 Day 27, n=12 | 65.8 Grams per Liter | Standard Deviation 4 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Albumin and Protein | Protein, Follow-up, Period 1 Day 13, n=1 | 60.0 Grams per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Albumin and Protein | Protein, Follow-up, Period 2 Day 21, n=1 | 63.0 Grams per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Albumin and Protein | Protein, Follow-up, Period 2 Day 27, n=1 | 70.0 Grams per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Albumin and Protein | Protein, Follow-up, n=15 | 63.7 Grams per Liter | Standard Deviation 2.55 |
Secondary
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
Samples for clinical chemistry assessment were collected for ALP, AST, ALT, CK and GGT. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | ALP, Day -1, n=15 | 62.7 International units per Liter | Standard Deviation 14.52 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | ALP, On-treatment, Period 1 Day 13, n=14 | 60.1 International units per Liter | Standard Deviation 14.34 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | ALP, On-treatment, Period 2 Day 21, n=13 | 60.7 International units per Liter | Standard Deviation 13.94 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | ALP, On-treatment, Period 2 Day 27, n=12 | 59.9 International units per Liter | Standard Deviation 17.83 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | ALP, Follow-up, Period 1 Day 13, n=1 | 51.0 International units per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | ALP, Follow-up, Period 2 Day 21, n=1 | 61.0 International units per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | ALP, Follow-up, Period 2 Day 27, n=1 | 56.0 International units per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | ALP, Follow-up, n=15 | 60.7 International units per Liter | Standard Deviation 13.35 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | ALT, Day -1, n=15 | 23.5 International units per Liter | Standard Deviation 7.07 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | ALT, On-treatment, Period 1 Day 13, n=14 | 25.5 International units per Liter | Standard Deviation 8.83 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | ALT, On-treatment, Period 2 Day 21, n=13 | 30.2 International units per Liter | Standard Deviation 20.12 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | ALT, On-treatment, Period 2 Day 27, n=12 | 30.8 International units per Liter | Standard Deviation 29.65 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | ALT, Follow-up, Period 1 Day 13, n=1 | 155.0 International units per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | ALT, Follow-up, Period 2 Day 21, n=1 | 39.0 International units per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | ALT, Follow-up, Period 2 Day 27, n=1 | 34.0 International units per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | ALT, Follow-up, n=15 | 37.3 International units per Liter | Standard Deviation 23.4 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | AST, Day -1, n=15 | 18.5 International units per Liter | Standard Deviation 3.62 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | AST, On-treatment, Period 1 Day 13, n=14 | 20.7 International units per Liter | Standard Deviation 6.85 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | AST, On-treatment, Period 2 Day 21, n=13 | 20.9 International units per Liter | Standard Deviation 5.87 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | AST, On-treatment, Period 2 Day 27, n=12 | 23.3 International units per Liter | Standard Deviation 11.48 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | AST, Follow-up, Period 1 Day 13, n=1 | 83.0 International units per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | AST, Follow-up, Period 2 Day 21, n=1 | 26.0 International units per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | AST, Follow-up, Period 2 Day 27, n=1 | 37.0 International units per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | AST, Follow-up, n=15 | 24.9 International units per Liter | Standard Deviation 9.44 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | CK, Day -1, n=15 | 133.6 International units per Liter | Standard Deviation 40.31 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | CK, On-treatment, Period 1 Day 13, n=14 | 227.1 International units per Liter | Standard Deviation 303.97 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | CK, On-treatment, Period 2 Day 21, n=13 | 104.2 International units per Liter | Standard Deviation 43.44 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | CK, On-treatment, Period 2 Day 27, n=12 | 88.7 International units per Liter | Standard Deviation 42.09 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | CK, Follow-up, Period 1 Day 13, n=1 | 1278.0 International units per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | CK, Follow-up, Period 2 Day 21, n=1 | 177.0 International units per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | CK, Follow-up, Period 2 Day 27, n=1 | 164.0 International units per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | CK, Follow-up, n=15 | 144.3 International units per Liter | Standard Deviation 80.81 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | GGT, Day -1, n=15 | 25.5 International units per Liter | Standard Deviation 14.97 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | GGT, On-treatment, Period 1 Day 13, n=14 | 22.6 International units per Liter | Standard Deviation 13.2 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | GGT, On-treatment, Period 2 Day 21, n=13 | 26.8 International units per Liter | Standard Deviation 23.95 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | GGT, On-treatment, Period 2 Day 27, n=12 | 28.1 International units per Liter | Standard Deviation 28.25 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | GGT, Follow-up, Period 1 Day 13, n=1 | 17.0 International units per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | GGT, Follow-up, Period 2 Day 21, n=1 | 36.0 International units per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | GGT, Follow-up, Period 2 Day 27, n=1 | 82.0 International units per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) | GGT, Follow-up, n=15 | 36.1 International units per Liter | Standard Deviation 33.77 |
Secondary
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Samples for clinical chemistry assessment were collected for Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Calcium, Day -1, n=15 | 2.31 Millimoles per Liter | Standard Deviation 0.0539 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Calcium, On-treatment, Period 1 Day 13, n=14 | 2.34 Millimoles per Liter | Standard Deviation 0.077 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Calcium, On-treatment, Period 2 Day 21, n=13 | 2.29 Millimoles per Liter | Standard Deviation 0.072 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Calcium, On-treatment, Period 2 Day 27, n=12 | 2.28 Millimoles per Liter | Standard Deviation 0.0844 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Calcium, Follow-up, Period 1 Day 13, n=1 | 2.27 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Calcium, Follow-up, Period 2 Day 21, n=1 | 2.38 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Calcium, Follow-up, Period 2 Day 27, n=1 | 2.06 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Calcium, Follow-up, n=15 | 2.28 Millimoles per Liter | Standard Deviation 0.04 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Chloride, Day -1, n=15 | 101.0 Millimoles per Liter | Standard Deviation 1.73 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Chloride, On-treatment, Period 1 Day 13, n=14 | 100.5 Millimoles per Liter | Standard Deviation 1.45 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Chloride, On-treatment, Period 2 Day 21, n=13 | 101.1 Millimoles per Liter | Standard Deviation 2.4 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Chloride, On-treatment, Period 2 Day 27, n=12 | 101.8 Millimoles per Liter | Standard Deviation 2.14 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Chloride, Follow-up, Period 1 Day 13, n=1 | 101.0 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Chloride, Follow-up, Period 2 Day 21, n=1 | 100.0 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Chloride, Follow-up, Period 2 Day 27, n=1 | 99.0 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Chloride, Follow-up, n=15 | 102.5 Millimoles per Liter | Standard Deviation 2.07 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Carbon Dioxide, Day -1, n=15 | 25.6 Millimoles per Liter | Standard Deviation 1.12 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Carbon Dioxide, On-treatment, Period 1 Day13, n=14 | 25.3 Millimoles per Liter | Standard Deviation 1.38 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Carbon Dioxide, On-treatment, Period 2 Day21, n=13 | 27.4 Millimoles per Liter | Standard Deviation 2.1 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Carbon Dioxide, On-treatment, Period 2 Day27, n=12 | 24.7 Millimoles per Liter | Standard Deviation 3.11 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Carbon Dioxide, Follow-up, Period 1 Day 13, n=1 | 25.0 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Carbon Dioxide, Follow-up, Period 2 Day 21, n=1 | 27.0 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Carbon Dioxide, Follow-up, Period 2 Day 27, n=1 | 20.0 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Carbon Dioxide, Follow-up, n=15 | 25.7 Millimoles per Liter | Standard Deviation 1.76 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Glucose, Day -1, n=15 | 5.27 Millimoles per Liter | Standard Deviation 1.077 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Glucose, On-treatment, Period 1 Day 13, n=14 | 5.51 Millimoles per Liter | Standard Deviation 0.487 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Glucose, On-treatment, Period 2 Day 21, n=13 | 5.45 Millimoles per Liter | Standard Deviation 0.399 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Glucose, On-treatment, Period 2 Day 27, n=12 | 5.95 Millimoles per Liter | Standard Deviation 1.103 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Glucose, Follow-up, Period 1 Day 13, n=1 | 5.00 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Glucose, Follow-up, Period 2 Day 21, n=1 | 5.40 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Glucose, Follow-up, Period 2 Day 27, n=1 | 6.00 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Glucose, Follow-up, n=15 | 5.35 Millimoles per Liter | Standard Deviation 0.374 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Potassium, Day -1, n=15 | 4.22 Millimoles per Liter | Standard Deviation 0.166 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Potassium, On-treatment, Period 1 Day 13, n=14 | 4.29 Millimoles per Liter | Standard Deviation 0.25 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Potassium, On-treatment, Period 2 Day 21, n=13 | 4.36 Millimoles per Liter | Standard Deviation 0.386 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Potassium, On-treatment, Period 2 Day 27, n=12 | 4.29 Millimoles per Liter | Standard Deviation 0.247 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Potassium, Follow-up, Period 1 Day 13, n=1 | 3.90 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Potassium, Follow-up, Period 2 Day 21, n=1 | 4.00 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Potassium, Follow-up, Period 2 Day 27, n=1 | 4.10 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Potassium, Follow-up, n=15 | 4.31 Millimoles per Liter | Standard Deviation 0.183 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Sodium, Day -1, n=15 | 141.1 Millimoles per Liter | Standard Deviation 1.28 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Sodium, On-treatment, Period 1 Day 13, n=14 | 139.6 Millimoles per Liter | Standard Deviation 1.82 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Sodium, On-treatment, Period 2 Day 21, n=13 | 140.3 Millimoles per Liter | Standard Deviation 2.36 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Sodium, On-treatment, Period 2 Day 27, n=12 | 139.8 Millimoles per Liter | Standard Deviation 2.09 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Sodium, Follow-up, Period 1 Day 13, n=1 | 139.0 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Sodium, Follow-up, Period 2 Day 21, n=1 | 140.0 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Sodium, Follow-up, Period 2 Day 27, n=1 | 137.0 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Sodium, Follow-up, n=15 | 141.1 Millimoles per Liter | Standard Deviation 2.02 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Urea, Day -1, n=15 | 5.73 Millimoles per Liter | Standard Deviation 1.4048 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Urea, On-treatment, Period 1 Day 13, n=14 | 5.19 Millimoles per Liter | Standard Deviation 1.083 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Urea, On-treatment, Period 2 Day 21, n=13 | 5.69 Millimoles per Liter | Standard Deviation 1.3678 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Urea, On-treatment, Period 2 Day 27, n=12 | 5.18 Millimoles per Liter | Standard Deviation 1.2104 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Urea, Follow-up, Period 1 Day 13, n=1 | 4.69 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Urea, Follow-up, Period 2 Day 21, n=1 | 2.79 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Urea, Follow-up, Period 2 Day 27, n=1 | 4.09 Millimoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea | Urea, Follow-up, n=15 | 5.34 Millimoles per Liter | Standard Deviation 1.2189 |
Secondary
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Samples for clinical chemistry assessment were collected for DB, bilirubin and creatinine. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Bilirubin, Day -1, n=15 | 9.8 Micromoles per Liter | Standard Deviation 6.72 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | DB, Day -1, n=15 | 3.5 Micromoles per Liter | Standard Deviation 2 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | DB, On-treatment, Period 1 Day 13, n=14 | 3.5 Micromoles per Liter | Standard Deviation 1.83 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | DB, On-treatment, Period 2 Day 21, n=13 | 2.4 Micromoles per Liter | Standard Deviation 1.45 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | DB, On-treatment, Period 2 Day 27, n=12 | 2.2 Micromoles per Liter | Standard Deviation 1.19 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | DB, Follow-up, Period 1 Day 13, n=1 | 4.0 Micromoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | DB, Follow-up, Period 2 Day 21, n=1 | 1.0 Micromoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | DB, Follow-up, Period 2 Day 27, n=1 | 2.0 Micromoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | DB, Follow-up, n=15 | 2.9 Micromoles per Liter | Standard Deviation 1.39 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Bilirubin, On-treatment, Period 1 Day 13, n=14 | 10.1 Micromoles per Liter | Standard Deviation 5.83 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Bilirubin, On-treatment, Period 2 Day 21, n=13 | 6.6 Micromoles per Liter | Standard Deviation 4.74 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Bilirubin, On-treatment, Period 2 Day 27, n=12 | 5.3 Micromoles per Liter | Standard Deviation 2.99 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Bilirubin, Follow-up, Period 1 Day 13, n=1 | 10.0 Micromoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Bilirubin, Follow-up, Period 2 Day 21, n=1 | 3.0 Micromoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Bilirubin, Follow-up, Period 2 Day 27, n=1 | 5.0 Micromoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Bilirubin, Follow-up, n=15 | 7.9 Micromoles per Liter | Standard Deviation 3.83 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Creatinine, Day -1, n=15 | 83.1 Micromoles per Liter | Standard Deviation 7.71 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Creatinine, On-treatment, Period 1 Day 13, n=14 | 85.9 Micromoles per Liter | Standard Deviation 11.02 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Creatinine, On-treatment, Period 2 Day 21, n=13 | 88.4 Micromoles per Liter | Standard Deviation 9.43 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Creatinine, On-treatment, Period 2 Day 27, n=12 | 83.8 Micromoles per Liter | Standard Deviation 10.69 |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Creatinine, Follow-up, Period 1 Day 13, n=1 | 64.0 Micromoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Creatinine, Follow-up, Period 2 Day 21, n=1 | 71.0 Micromoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Creatinine, Follow-up, Period 2 Day 27, n=1 | 91.0 Micromoles per Liter | — |
| CAB 30 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine | Creatinine, Follow-up, n=15 | 80.7 Micromoles per Liter | Standard Deviation 9.65 |
Secondary
Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin
Blood samples for hematology assessment was collected for Eryrocyte Mean Corpuscular Hemoglobin. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB 30 mg | Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin | Day -1, n=15 | 29.77 Picograms | Standard Deviation 1.457 |
| CAB 30 mg | Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin | On-treatment, Period 1 Day 13, n=14 | 29.54 Picograms | Standard Deviation 1.536 |
| CAB 30 mg | Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin | On-treatment, Period 2 Day 21, n=13 | 30.13 Picograms | Standard Deviation 1.329 |
| CAB 30 mg | Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin | On-treatment, Period 2 Day 27, n=12 | 29.74 Picograms | Standard Deviation 1.466 |
| CAB 30 mg | Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin | Follow-up, Period 1 Day 13, n=1 | 29.30 Picograms | — |
| CAB 30 mg | Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin | Follow-up, Period 2 Day 21, n=1 | 27.80 Picograms | — |
| CAB 30 mg | Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin | Follow-up, Period 2 Day 27, n=1 | 30.90 Picograms | — |
| CAB 30 mg | Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin | Follow-up, n=15 | 29.49 Picograms | Standard Deviation 1.451 |
Secondary
Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume
Blood samples for hematology assessment was collected for Erythrocyte Mean Corpuscular Volume. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB 30 mg | Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume | Day -1, n=15 | 84.60 Femtoliters | Standard Deviation 3.522 |
| CAB 30 mg | Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume | On-treatment, Period 1 Day 13, n=14 | 87.94 Femtoliters | Standard Deviation 2.829 |
| CAB 30 mg | Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume | On-treatment, Period 2 Day 21, n=13 | 85.39 Femtoliters | Standard Deviation 3.367 |
| CAB 30 mg | Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume | On-treatment, Period 2 Day 27, n=12 | 87.73 Femtoliters | Standard Deviation 3.997 |
| CAB 30 mg | Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume | Follow-up, Period 1 Day 13, n=1 | 88.20 Femtoliters | — |
| CAB 30 mg | Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume | Follow-up, Period 2 Day 21, n=1 | 79.20 Femtoliters | — |
| CAB 30 mg | Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume | Follow-up, Period 2 Day 27, n=1 | 87.10 Femtoliters | — |
| CAB 30 mg | Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume | Follow-up, n=15 | 86.59 Femtoliters | Standard Deviation 3.618 |
Secondary
Assessment of Hematology Parameter: Hemoglobin
Blood samples for hematology assessment was collected for Hemoglobin. NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB 30 mg | Assessment of Hematology Parameter: Hemoglobin | Day -1, n=15 | 144.7 Grams per Liter | Standard Deviation 7.25 |
| CAB 30 mg | Assessment of Hematology Parameter: Hemoglobin | Period 1 Day 13, n=14 | 143.5 Grams per Liter | Standard Deviation 7.51 |
| CAB 30 mg | Assessment of Hematology Parameter: Hemoglobin | Period 2 Day 21, n=13 | 146.4 Grams per Liter | Standard Deviation 8.13 |
| CAB 30 mg | Assessment of Hematology Parameter: Hemoglobin | Period 2 Day 27, n=12 | 144.2 Grams per Liter | Standard Deviation 9.93 |
| CAB 30 mg | Assessment of Hematology Parameter: Hemoglobin | Follow-up, Period 1 Day 13, n=1 | 137.0 Grams per Liter | — |
| CAB 30 mg | Assessment of Hematology Parameter: Hemoglobin | Follow-up, Period 2 Day 21, n=1 | 147.0 Grams per Liter | — |
| CAB 30 mg | Assessment of Hematology Parameter: Hemoglobin | Follow-up, Period 2 Day 27, n=1 | 146.0 Grams per Liter | — |
| CAB 30 mg | Assessment of Hematology Parameter: Hemoglobin | Follow-up, n=15 | 140.1 Grams per Liter | Standard Deviation 6.04 |
Secondary
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Blood samples for hematology assessment were collected for basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day -1, n=15 | 0.025 10^9 cells/Liter | Standard Deviation 0.0119 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, On-treatment, Period 1 Day 13, n=14 | 0.031 10^9 cells/Liter | Standard Deviation 0.0141 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, On-treatment, Period 2 Day 21, n=13 | 0.028 10^9 cells/Liter | Standard Deviation 0.0124 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, On-treatment, Period 2 Day 27, n=12 | 0.018 10^9 cells/Liter | Standard Deviation 0.0106 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Follow-up, Period 1 Day 13, n=1 | 0.030 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Follow-up, Period 2 Day 21, n=1 | 0.010 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Follow-up, Period 2 Day 27, n=1 | 0.010 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Follow-up, n=15 | 0.023 10^9 cells/Liter | Standard Deviation 0.0098 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, On-treatment, Day -1, n=15 | 0.259 10^9 cells/Liter | Standard Deviation 0.2001 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, On-treatment, Period 1 Day 13, n=14 | 0.285 10^9 cells/Liter | Standard Deviation 0.2264 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, On-treatment, Period 2 Day 21, n=13 | 0.315 10^9 cells/Liter | Standard Deviation 0.2306 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, On-treatment, Period 2 Day 27, n=12 | 0.219 10^9 cells/Liter | Standard Deviation 0.2815 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Follow-up, Period 1 Day 13, n=1 | 0.370 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Follow-up, Period 2 Day 21, n=1 | 0.010 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Follow-up, Period 2 Day 27, n=1 | 0.120 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Follow-up, n=15 | 0.273 10^9 cells/Liter | Standard Deviation 0.2621 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day -1, n=15 | 2.509 10^9 cells/Liter | Standard Deviation 0.7383 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, On-treatment, Period 1 Day 13, n=14 | 2.224 10^9 cells/Liter | Standard Deviation 0.6596 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, On-treatment, Period 2 Day 21, n=13 | 2.071 10^9 cells/Liter | Standard Deviation 0.8625 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, On-treatment, Period 2 Day 27, n=12 | 1.551 10^9 cells/Liter | Standard Deviation 0.6554 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Follow-up, Period 1 Day 13, n=1 | 1.200 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Follow-up, Period 2 Day 21, n=1 | 0.310 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Follow-up, Period 2 Day 27, n=1 | 0.480 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Follow-up, n=15 | 2.140 10^9 cells/Liter | Standard Deviation 0.7373 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day -1, n=15 | 0.561 10^9 cells/Liter | Standard Deviation 0.157 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, On-treatment, Period 1 Day 13, n=14 | 0.548 10^9 cells/Liter | Standard Deviation 0.1397 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, On-treatment, Period 2 Day 21, n=13 | 0.628 10^9 cells/Liter | Standard Deviation 0.1579 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, On-treatment, Period 2 Day 27, n=12 | 0.488 10^9 cells/Liter | Standard Deviation 0.1442 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Follow-up, Period 1 Day 13, n=1 | 0.360 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Follow-up, Period 2 Day 21, n=1 | 0.480 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Follow-up, Period 2 Day 27, n=1 | 0.790 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Follow-up, n=15 | 0.545 10^9 cells/Liter | Standard Deviation 0.1503 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day -1, n=15 | 4.279 10^9 cells/Liter | Standard Deviation 1.2269 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, On-treatment, Period 1 Day 13, n=14 | 3.306 10^9 cells/Liter | Standard Deviation 0.9964 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, On-treatment, Period 2 Day 21, n=13 | 2.818 10^9 cells/Liter | Standard Deviation 1.0823 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, On-treatment, Period 2 Day 21, n=12 | 1.979 10^9 cells/Liter | Standard Deviation 0.6006 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Follow-up, Period 1 Day 13, n=1 | 2.340 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Follow-up, Period 2 Day 21, n=1 | 3.830 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Follow-up, Period 2 Day 27, n=1 | 3.970 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Follow-up, n=15 | 2.840 10^9 cells/Liter | Standard Deviation 0.8665 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day -1, n=15 | 234.7 10^9 cells/Liter | Standard Deviation 34.58 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, On-treatment, Period 1 Day 13, n=14 | 210.7 10^9 cells/Liter | Standard Deviation 31.46 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, On-treatment, Period 2 Day 21, n=13 | 214.5 10^9 cells/Liter | Standard Deviation 31.04 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, On-treatment, Period 2 Day 27, n=12 | 193.9 10^9 cells/Liter | Standard Deviation 34.47 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Follow-up, Period 1 Day 13, n=1 | 206.0 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Follow-up, Period 2 Day 21, n=1 | 206.0 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Follow-up, Period 2 Day 27, n=1 | 169.0 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Follow-up, n=15 | 229.8 10^9 cells/Liter | Standard Deviation 45.57 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day -1, n=15 | 7.633 10^9 cells/Liter | Standard Deviation 1.6572 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, On-treatment, Period 1 Day 13, n=14 | 6.394 10^9 cells/Liter | Standard Deviation 1.5268 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, On-treatment, Period 2 Day 21, n=13 | 5.859 10^9 cells/Liter | Standard Deviation 1.5835 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, On-treatment, Period 2 Day 27, n=12 | 4.256 10^9 cells/Liter | Standard Deviation 1.3035 |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Follow-up, Period 1 Day 13, n=1 | 4.300 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Follow-up, Period 2 Day 21, n=1 | 4.640 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Follow-up, Period 2 Day 27, n=1 | 5.370 10^9 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Follow-up, n=15 | 5.822 10^9 cells/Liter | Standard Deviation 1.3583 |
Secondary
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Blood samples for hematology assessment were collected for Erythrocytes and reticulocytes. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Day -1, n=15 | 4.870 10^12 cells/Liter | Standard Deviation 0.3068 |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, On-treatment, Period 1 Day 13, n=14 | 4.869 10^12 cells/Liter | Standard Deviation 0.34 |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, On-treatment, Period 2 Day 21, n=13 | 4.868 10^12 cells/Liter | Standard Deviation 0.3173 |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, On-treatment, Period 2 Day 27, n=12 | 4.855 10^12 cells/Liter | Standard Deviation 0.3605 |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Follow-up, Period 1 Day 13, n=1 | 4.680 10^12 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Follow-up, Period 2 Day 21, n=1 | 5.290 10^12 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Follow-up, Period 2 Day 27, n=1 | 4.730 10^12 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Erythrocytes, Follow-up, n=15 | 4.761 10^12 cells/Liter | Standard Deviation 0.3372 |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Day -1, n=15 | 0.043 10^12 cells/Liter | Standard Deviation 0.01246 |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, On-treatment, Period 1 Day 13, n=14 | 0.040 10^12 cells/Liter | Standard Deviation 0.0135 |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, On-treatment, Period 2 Day 21, n=13 | 0.040 10^12 cells/Liter | Standard Deviation 0.01097 |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, On-treatment, Period 2 Day 27, n=12 | 0.028 10^12 cells/Liter | Standard Deviation 0.00997 |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Follow-up, Period 1 Day 13, n=1 | 0.064 10^12 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Follow-up, Period 2 Day 21, n=1 | 0.051 10^12 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Follow-up, Period 2 Day 27, n=1 | 0.014 10^12 cells/Liter | — |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes and Reticulocytes | Reticulocytes, Follow-up, n=15 | 0.049 10^12 cells/Liter | Standard Deviation 0.01415 |
Secondary
Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW)
Blood samples for hematology assessment was collected for EDW. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW) | Day -1, n=15 | 12.91 Percentage of EDW | Standard Deviation 0.513 |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW) | On-treatment, Period 1 Day 13, n=14 | 13.13 Percentage of EDW | Standard Deviation 0.595 |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW) | On-treatment, Period 2 Day 21, n=13 | 12.89 Percentage of EDW | Standard Deviation 0.641 |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW) | On-treatment, Period 2 Day 27, n=12 | 12.90 Percentage of EDW | Standard Deviation 0.624 |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW) | Follow-up, Period 1 Day 13, n=1 | 13.40 Percentage of EDW | — |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW) | Follow-up, Period 2 Day 21, n=1 | 13.60 Percentage of EDW | — |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW) | Follow-up, Period 2 Day 27, n=1 | 12.40 Percentage of EDW | — |
| CAB 30 mg | Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW) | Follow-up, n=15 | 12.90 Percentage of EDW | Standard Deviation 0.535 |
Secondary
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
Blood samples for hematology assessment were collected for Hematocrit and R/E. NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB 30 mg | Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | Hematocrit, Day -1, n=15 | 0.411 Proportion of red blood cells in blood | Standard Deviation 0.02107 |
| CAB 30 mg | Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | Hematocrit, On-treatment, Period 1 Day 13, n=14 | 0.427 Proportion of red blood cells in blood | Standard Deviation 0.02432 |
| CAB 30 mg | Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | Hematocrit, On-treatment, Period 2 Day 21, n=13 | 0.415 Proportion of red blood cells in blood | Standard Deviation 0.02277 |
| CAB 30 mg | Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | Hematocrit, On-treatment, Period 2 Day 27, n=12 | 0.425 Proportion of red blood cells in blood | Standard Deviation 0.02139 |
| CAB 30 mg | Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | Hematocrit, Follow-up, Period 1 Day 13, n=1 | 0.413 Proportion of red blood cells in blood | — |
| CAB 30 mg | Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | Hematocrit, Follow-up, Period 2 Day 21, n=1 | 0.419 Proportion of red blood cells in blood | — |
| CAB 30 mg | Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | Hematocrit, Follow-up, Period 2 Day 27, n=1 | 0.412 Proportion of red blood cells in blood | — |
| CAB 30 mg | Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | Hematocrit, Follow-up, n=15 | 0.411 Proportion of red blood cells in blood | Standard Deviation 0.01766 |
| CAB 30 mg | Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | R/E, Day -1, n=15 | 0.008 Proportion of red blood cells in blood | Standard Deviation 0.00228 |
| CAB 30 mg | Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | R/E, On-treatment, Period 1 Day 13, n=14 | 0.008 Proportion of red blood cells in blood | Standard Deviation 0.00248 |
| CAB 30 mg | Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | R/E, On-treatment, Period 2 Day 21, n=13 | 0.008 Proportion of red blood cells in blood | Standard Deviation 0.00209 |
| CAB 30 mg | Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | R/E, On-treatment, Period 2 Day 27, n=12 | 0.006 Proportion of red blood cells in blood | Standard Deviation 0.00219 |
| CAB 30 mg | Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | R/E, Follow-up, Period 1 Day 13, n=1 | 0.013 Proportion of red blood cells in blood | — |
| CAB 30 mg | Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | R/E, Follow-up, Period 2 Day 21, n=1 | 0.009 Proportion of red blood cells in blood | — |
| CAB 30 mg | Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | R/E, Follow-up, Period 2 Day 27, n=1 | 0.003 Proportion of red blood cells in blood | — |
| CAB 30 mg | Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E) | R/E, Follow-up, n=15 | 0.010 Proportion of red blood cells in blood | Standard Deviation 0.0027 |
Secondary
Assessment of Plasma CAB PK Parameter: Concentration at the End of the Dosing Interval (Ctau)
Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. Comparisons were made for the repeated dose PK parameters of CAB when given alone in Period 1 and when co-administered with steady-state RBT in Period 2.
Time frame: Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28
Population: PK Summary Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB 30 mg | Assessment of Plasma CAB PK Parameter: Concentration at the End of the Dosing Interval (Ctau) | 3.359 Micrograms per milliliter | Geometric Coefficient of Variation 34.3 |
| RBT 300 mg + CAB 30 mg | Assessment of Plasma CAB PK Parameter: Concentration at the End of the Dosing Interval (Ctau) | 2.479 Micrograms per milliliter | Geometric Coefficient of Variation 36.3 |
90% CI: [0.702, 0.776]
Secondary
Assessment of Plasma CAB PK Parameter: Terminal Phase Half-life (t1/2)
Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. Apparent terminal half-life was calculated as: t1/2 = ln2 / Lambda\_z, where Lambda\_z is the terminal phase rate constant. Plasma t1/2 was not estimated for either period due to limited PK sampling in the terminal phase.
Time frame: Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28
Population: PK Summary Population. Plasma t1/2 was not estimated for either period due to limited PK sampling in the terminal phase.
Secondary
Assessment of Plasma CAB PK Parameter: The Apparent Oral Clearance (CL/F)
Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. CL/F was calculated as CL/F =Dose/AUC(0 to tau).
Time frame: Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28
Population: PK Summary Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB 30 mg | Assessment of Plasma CAB PK Parameter: The Apparent Oral Clearance (CL/F) | 0.289 Liters per hour | Geometric Coefficient of Variation 28.3 |
| RBT 300 mg + CAB 30 mg | Assessment of Plasma CAB PK Parameter: The Apparent Oral Clearance (CL/F) | 0.367 Liters per hour | Geometric Coefficient of Variation 29.9 |
90% CI: [1.204, 1.345]
Secondary
Assessment of Plasma CAB PK Parameter: Time of Occurrence of Cmax (Tmax)
Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. Tmax was determined directly from the concentration-time data.
Time frame: Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28
Population: PK Summary Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CAB 30 mg | Assessment of Plasma CAB PK Parameter: Time of Occurrence of Cmax (Tmax) | 3.000 Hours |
| RBT 300 mg + CAB 30 mg | Assessment of Plasma CAB PK Parameter: Time of Occurrence of Cmax (Tmax) | 2.500 Hours |
Secondary
Change From Baseline in Pulse Rate
Vital signs measurement was done in semi-supine position after 10 minutes rest and included pulse rate. Two pulse rate measurement were taken at pre-dose on Day 1, at least 1 minute apart. The mean value recorded at pre-dose was classified as Baseline. Single pulse rate was obtained at all other time points during the study. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline to follow-up (10 to 14 days after last dose)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB 30 mg | Change From Baseline in Pulse Rate | On-treatment, Period 1 Day 14, n=14 | -4.5 Beats/minute | Standard Deviation 8.31 |
| CAB 30 mg | Change From Baseline in Pulse Rate | On-treatment, Period 2 Day 21, n=13 | -6.2 Beats/minute | Standard Deviation 9.98 |
| CAB 30 mg | Change From Baseline in Pulse Rate | On-treatment, Period 2 Day 28, n=12 | 3.4 Beats/minute | Standard Deviation 9.52 |
| CAB 30 mg | Change From Baseline in Pulse Rate | Follow-up, Period 2 Day 21, n=1 | 39.0 Beats/minute | — |
| CAB 30 mg | Change From Baseline in Pulse Rate | Follow-up, n=15 | -1.3 Beats/minute | Standard Deviation 10.58 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Vital signs measurement was done in semi-supine position after 10 minutes rest and included SBP and DBP. Two blood pressure measurement were taken at pre-dose on Day 1, at least 1 minute apart. The mean value recorded at pre-dose was classified as Baseline. Single blood pressure was obtained at all other time points during the study. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline to follow-up (10 to 14 days after last dose)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB 30 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, On-treatment, Period 1 Day 14, n=14 | -2.5 Millimeters of Mercury | Standard Deviation 9.17 |
| CAB 30 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, On-treatment, Period 2 Day 21, n=13 | 1.5 Millimeters of Mercury | Standard Deviation 11.9 |
| CAB 30 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, On-treatment, Period 2 Day 28, n=12 | 0.5 Millimeters of Mercury | Standard Deviation 8.74 |
| CAB 30 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Follow-up, Period 2 Day 21, n=1 | 17.0 Millimeters of Mercury | — |
| CAB 30 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Follow-up, n=15 | 3.7 Millimeters of Mercury | Standard Deviation 12.85 |
| CAB 30 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, On-treatment, Period 1 Day 14, n=14 | 0.8 Millimeters of Mercury | Standard Deviation 7.61 |
| CAB 30 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, On-treatment, Period 2 Day 21, n=13 | 2.0 Millimeters of Mercury | Standard Deviation 9.1 |
| CAB 30 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, On-treatment, Period 2 Day 28, n=12 | -1.6 Millimeters of Mercury | Standard Deviation 4.21 |
| CAB 30 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Follow-up, Period 2 Day 21, n=1 | 9.5 Millimeters of Mercury | — |
| CAB 30 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Follow-up, n=15 | 3.3 Millimeters of Mercury | Standard Deviation 9.04 |
Secondary
Concurrent Medication Assessment in Treatment Period 1 and 2
Concurrent medications included paracetamol and ibuprofen. Number of participants who took concurrent medications during the study are presented.
Time frame: Up to 10 weeks
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB 30 mg | Concurrent Medication Assessment in Treatment Period 1 and 2 | Paracetamol | 0 Participants |
| CAB 30 mg | Concurrent Medication Assessment in Treatment Period 1 and 2 | Ibuprofen | 0 Participants |
| RBT 300 mg + CAB 30 mg | Concurrent Medication Assessment in Treatment Period 1 and 2 | Paracetamol | 3 Participants |
| RBT 300 mg + CAB 30 mg | Concurrent Medication Assessment in Treatment Period 1 and 2 | Ibuprofen | 1 Participants |
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
ECG measurements was performed with the participant in a semi-supine position having rested in this position for at least 10 minutes beforehand. Data has been presented for Period 1, Day 14 pre-dose which showed abnormal- not clinically significant ECG finding. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Day 1, 14, 21, 28 and follow-up (10 to 14 days after last dose)
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAB 30 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 1 Participants |
| RBT 300 mg + CAB 30 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 0 Participants |
Secondary
Number of Participants With Abnormal Urinalysis Result
Samples for urinalysis assessment was collected at Day -1, Day 13, Day 21, Day 27 and during follow-up period (10 to 14 daya after last dose). Data for participants with abnormal urinalysis results has been presented.
Time frame: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAB 30 mg | Number of Participants With Abnormal Urinalysis Result | 0 Participants |
| RBT 300 mg + CAB 30 mg | Number of Participants With Abnormal Urinalysis Result | 0 Participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect and associated with liver injury and impaired liver function. Safety Population comprised of all participants who enrolled in the study and received at least one dose of study drug.
Time frame: Up to 10 weeks
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB 30 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 1 Participants |
| CAB 30 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| RBT 300 mg + CAB 30 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 7 Participants |
| RBT 300 mg + CAB 30 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 1 Participants |