Diabetic Kidney Disease
Conditions
Brief summary
The primary objective of this study is to evaluate the pharmacokinetics (PK) of selonsertib in participants with impaired hepatic function relative to matched, healthy controls.
Interventions
DRUGSelonsertib
6 mg tablets administered orally in fed state
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: All participants: * Body mass index (BMI) from 18 to 40 kg/m\^2, inclusive at study screening * Creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening Participants with impaired hepatic function: * Aside from hepatic insufficiency, participants must be sufficiently healthy for study participation based upon screening evaluations. * Must have diagnosis of chronic (\> 6 months), stable hepatic impairment with no clinically significant change in hepatic status within the 3 months (90 days) prior to study drug administration (Day 1). * Participants with severe hepatic impairment must have a score on the Child-Pugh-Turcotte scale of 10-15 at screening. * Participants with moderate hepatic impairment must have a score on the Child-Pugh-Turcotte scale of 7-9 at screening. * Participants with mild hepatic impairment must have a score on the Child-Pugh-Turcotte scale of 5-6 at screening. Healthy participants (matched control): * Must be in good health based upon screening evaluations. Key
Exclusion criteria
All participants: * Pregnant or lactating females * Have received any investigational compound or device within 30 days prior to study dosing * Current alcohol or substance abuse * A positive test result for human immunodeficiency virus (HIV-1/2) antibody * Have poor venous access that limits phlebotomy * Have been treated with systemic steroids, anti-HIV agents, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or expected to receive these agents during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) that would be contraindicated for other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509 | 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample. | AUCinf is defined as the concentration of drug extrapolated to infinite time. |
| PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509 | 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample. | AUClast is defined as the concentration of drug from time zero to the last observable concentration. |
| PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509 | 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample. | Cmax is defined as the maximum concentration of drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Study Drug-related Adverse Events (AEs) | Day 1 plus 30 days | An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs were defined as events that met one of the following criteria: 1) Any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; or 2) Any AEs leading to premature discontinuation of study drug. |
| Percentage of Participants Experiencing Any Treatment-Emergent and Grade ≥ 3 Laboratory Abnormalities | Day 1 plus 30 days | Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from predose at any postdose visit, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study drug. If the relevant baseline laboratory value was missing, then any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment-emergent. Severity grades were defined based on modified Common Terminology Criteria for Adverse Events (CTCAE) Laboratory Abnormality and Adverse Event Severity Grading, where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. The most severe graded abnormality from all tests was counted for each participant. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at study sites in United States. The first participant was screened on 17 August 2015. The last study visit occurred on 15 December 2015.
Pre-assignment details
107 participants were screened. In the control groups (normal hepatic function), each participant was matched for age, gender, race, and body mass index with a participant in the hepatic impairment group. 22 total unique participants with normal hepatic function were enrolled in Cohorts 1, 2, and 3. 3 participants served as matched control in both Cohort 1 and 2. 1 participant served as a matched control in both Cohort 1 and 3. 4 participants served as matched control in both Cohort 2 and 3.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Moderate Hepatic Impairment Participants with moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1. | 10 |
| Cohort 2: Severe Hepatic Impairment Participants with severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1. | 10 |
| Cohort 3: Mild Hepatic Impairment Participants with mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1. | 10 |
| Healthy Control Matched normal hepatic function participants received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1. | 22 |
| Total | 52 |
Baseline characteristics
| Characteristic | Cohort 1: Moderate Hepatic Impairment | Cohort 2: Severe Hepatic Impairment | Cohort 3: Mild Hepatic Impairment | Healthy Control | Total |
|---|---|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 5 | 54 years STANDARD_DEVIATION 5.8 | 53 years STANDARD_DEVIATION 10.4 | 53 years STANDARD_DEVIATION 8.4 | 54 years STANDARD_DEVIATION 7.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 8 Participants | 4 Participants | 12 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 2 Participants | 6 Participants | 10 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 0 Participants | 7 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 10 Participants | 9 Participants | 14 Participants | 40 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 3 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 7 Participants | 17 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 10 | 0 / 10 | 2 / 10 | 2 / 22 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 22 |
Outcome results
Primary
Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Time frame: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample.
Population: PK Analysis Set included all enrolled participants who received at least 1 dose of selonsertib and had at least 1 evaluable PK concentration data value reported by the PK laboratory for the respective analytes. 3 participants served as matched control in both Cohort 1 and 2. 1 participant served as a matched control in both Cohort 1 and 3. 4 participants served as matched control in both Cohort 2 and 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Moderate Hepatic Impairment | Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509 | AUCinf of Selonsertib | 3316.1 hr*ng/mL | Standard Deviation 1734.11 |
| Cohort 1: Moderate Hepatic Impairment | Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509 | AUCinf of GS-607509 | 5941.8 hr*ng/mL | Standard Deviation 2286.8 |
| Cohort 2: Severe Hepatic Impairment | Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509 | AUCinf of Selonsertib | 3266.7 hr*ng/mL | Standard Deviation 766.39 |
| Cohort 2: Severe Hepatic Impairment | Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509 | AUCinf of GS-607509 | 5711.2 hr*ng/mL | Standard Deviation 3401.94 |
| Cohort 3: Mild Hepatic Impairment | Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509 | AUCinf of Selonsertib | 2962.1 hr*ng/mL | Standard Deviation 901.12 |
| Cohort 3: Mild Hepatic Impairment | Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509 | AUCinf of GS-607509 | 10203.6 hr*ng/mL | Standard Deviation 8689.39 |
| Matched Healthy Control for Cohort 1 | Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509 | AUCinf of Selonsertib | 2835.3 hr*ng/mL | Standard Deviation 499.58 |
| Matched Healthy Control for Cohort 1 | Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509 | AUCinf of GS-607509 | 9993.3 hr*ng/mL | Standard Deviation 4599.91 |
| Matched Healthy Control for Cohort 2 | Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509 | AUCinf of Selonsertib | 2277.9 hr*ng/mL | Standard Deviation 490.96 |
| Matched Healthy Control for Cohort 2 | Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509 | AUCinf of GS-607509 | 9603.4 hr*ng/mL | Standard Deviation 8057.84 |
| Matched Healthy Control for Cohort 3 | Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509 | AUCinf of Selonsertib | 2711.6 hr*ng/mL | Standard Deviation 919.83 |
| Matched Healthy Control for Cohort 3 | Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509 | AUCinf of GS-607509 | 9846.6 hr*ng/mL | Standard Deviation 8954.4 |
Comparison: AUCinf of selonsertib90% CI: [77.08, 143.23]
Comparison: AUCinf of selonsertib90% CI: [120.52, 168.84]
Comparison: AUCinf of selonsertib90% CI: [86.99, 140.49]
Comparison: AUCinf of GS-60750990% CI: [43.84, 87.81]
Comparison: AUCinf of GS-60750990% CI: [36.72, 120.21]
Comparison: AUCinf of GS-60750990% CI: [51.75, 206.83]
Primary
PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Time frame: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample.
Population: Participants in the PK Analysis Set were analyzed. 3 participants served as matched control in both Cohort 1 and 2. 1 participant served as a matched control in both Cohort 1 and 3. 4 participants served as matched control in both Cohort 2 and 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Moderate Hepatic Impairment | PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509 | AUClast of Selonsertib | 2964.1 hr*ng/mL | Standard Deviation 1493.69 |
| Cohort 1: Moderate Hepatic Impairment | PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509 | AUClast of GS-607509 | 5405.2 hr*ng/mL | Standard Deviation 2211.86 |
| Cohort 2: Severe Hepatic Impairment | PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509 | AUClast of Selonsertib | 3032.7 hr*ng/mL | Standard Deviation 728.55 |
| Cohort 2: Severe Hepatic Impairment | PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509 | AUClast of GS-607509 | 4868.0 hr*ng/mL | Standard Deviation 3072.43 |
| Cohort 3: Mild Hepatic Impairment | PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509 | AUClast of Selonsertib | 2790.8 hr*ng/mL | Standard Deviation 847.18 |
| Cohort 3: Mild Hepatic Impairment | PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509 | AUClast of GS-607509 | 8475.8 hr*ng/mL | Standard Deviation 7165.86 |
| Matched Healthy Control for Cohort 1 | PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509 | AUClast of Selonsertib | 2679.9 hr*ng/mL | Standard Deviation 486.23 |
| Matched Healthy Control for Cohort 1 | PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509 | AUClast of GS-607509 | 9117.6 hr*ng/mL | Standard Deviation 4127.22 |
| Matched Healthy Control for Cohort 2 | PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509 | AUClast of Selonsertib | 2129.7 hr*ng/mL | Standard Deviation 493.83 |
| Matched Healthy Control for Cohort 2 | PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509 | AUClast of GS-607509 | 8157.5 hr*ng/mL | Standard Deviation 6019.61 |
| Matched Healthy Control for Cohort 3 | PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509 | AUClast of Selonsertib | 2530.9 hr*ng/mL | Standard Deviation 902.55 |
| Matched Healthy Control for Cohort 3 | PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509 | AUClast of GS-607509 | 8326.5 hr*ng/mL | Standard Deviation 6604.26 |
Comparison: AUClast of selonsertib90% CI: [73.38, 135.92]
Comparison: AUClast of selonsertib90% CI: [118.5, 169.55]
Comparison: AUClast of selonsertib90% CI: [87.69, 143.65]
Comparison: AUClast of GS-60750990% CI: [43.06, 86.98]
Comparison: AUClast of GS-60750990% CI: [33.62, 110.91]
Comparison: AUClast of GS-60750990% CI: [48.47, 190.67]
Primary
PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509
Cmax is defined as the maximum concentration of drug.
Time frame: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample.
Population: Participants in the PK Analysis Set were analyzed. 3 participants served as matched control in both Cohort 1 and 2. 1 participant served as a matched control in both Cohort 1 and 3. 4 participants served as matched control in both Cohort 2 and 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Moderate Hepatic Impairment | PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509 | Cmax of Selonsertib | 93.7 ng/mL | Standard Deviation 20.66 |
| Cohort 1: Moderate Hepatic Impairment | PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509 | Cmax of GS-607509 | 44.1 ng/mL | Standard Deviation 15.01 |
| Cohort 2: Severe Hepatic Impairment | PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509 | Cmax of Selonsertib | 82.4 ng/mL | Standard Deviation 10.63 |
| Cohort 2: Severe Hepatic Impairment | PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509 | Cmax of GS-607509 | 31.2 ng/mL | Standard Deviation 15.34 |
| Cohort 3: Mild Hepatic Impairment | PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509 | Cmax of Selonsertib | 110.6 ng/mL | Standard Deviation 24.77 |
| Cohort 3: Mild Hepatic Impairment | PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509 | Cmax of GS-607509 | 63.5 ng/mL | Standard Deviation 31.42 |
| Matched Healthy Control for Cohort 1 | PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509 | Cmax of Selonsertib | 105.4 ng/mL | Standard Deviation 22.13 |
| Matched Healthy Control for Cohort 1 | PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509 | Cmax of GS-607509 | 62.3 ng/mL | Standard Deviation 23.44 |
| Matched Healthy Control for Cohort 2 | PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509 | Cmax of Selonsertib | 91.9 ng/mL | Standard Deviation 22.01 |
| Matched Healthy Control for Cohort 2 | PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509 | Cmax of GS-607509 | 63.2 ng/mL | Standard Deviation 27.03 |
| Matched Healthy Control for Cohort 3 | PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509 | Cmax of Selonsertib | 110.3 ng/mL | Standard Deviation 23.4 |
| Matched Healthy Control for Cohort 3 | PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509 | Cmax of GS-607509 | 64.2 ng/mL | Standard Deviation 21.99 |
Comparison: Cmax of selonsertib90% CI: [74.83, 105.1]
Comparison: Cmax of selonsertib90% CI: [78.76, 105.52]
Comparison: Cmax of selonsertib90% CI: [83.73, 119.88]
Comparison: Cmax of GS-60750990% CI: [54.58, 93.5]
Comparison: Cmax of GS-60750990% CI: [32.59, 67.54]
Comparison: Cmax of GS-60750990% CI: [67.6, 130.5]
Secondary
Percentage of Participants Experiencing Any Treatment-Emergent and Grade ≥ 3 Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from predose at any postdose visit, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study drug. If the relevant baseline laboratory value was missing, then any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment-emergent. Severity grades were defined based on modified Common Terminology Criteria for Adverse Events (CTCAE) Laboratory Abnormality and Adverse Event Severity Grading, where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. The most severe graded abnormality from all tests was counted for each participant.
Time frame: Day 1 plus 30 days
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: Moderate Hepatic Impairment | Percentage of Participants Experiencing Any Treatment-Emergent and Grade ≥ 3 Laboratory Abnormalities | Any Treatment-Emergent Laboratory Abnormalities | 90.0 percentage of participants |
| Cohort 1: Moderate Hepatic Impairment | Percentage of Participants Experiencing Any Treatment-Emergent and Grade ≥ 3 Laboratory Abnormalities | Grade ≥ 3 Laboratory Abnormalities | 20.0 percentage of participants |
| Cohort 2: Severe Hepatic Impairment | Percentage of Participants Experiencing Any Treatment-Emergent and Grade ≥ 3 Laboratory Abnormalities | Grade ≥ 3 Laboratory Abnormalities | 40.0 percentage of participants |
| Cohort 2: Severe Hepatic Impairment | Percentage of Participants Experiencing Any Treatment-Emergent and Grade ≥ 3 Laboratory Abnormalities | Any Treatment-Emergent Laboratory Abnormalities | 90.0 percentage of participants |
| Cohort 3: Mild Hepatic Impairment | Percentage of Participants Experiencing Any Treatment-Emergent and Grade ≥ 3 Laboratory Abnormalities | Any Treatment-Emergent Laboratory Abnormalities | 70.0 percentage of participants |
| Cohort 3: Mild Hepatic Impairment | Percentage of Participants Experiencing Any Treatment-Emergent and Grade ≥ 3 Laboratory Abnormalities | Grade ≥ 3 Laboratory Abnormalities | 10.0 percentage of participants |
| Matched Healthy Control for Cohort 1 | Percentage of Participants Experiencing Any Treatment-Emergent and Grade ≥ 3 Laboratory Abnormalities | Any Treatment-Emergent Laboratory Abnormalities | 59.1 percentage of participants |
| Matched Healthy Control for Cohort 1 | Percentage of Participants Experiencing Any Treatment-Emergent and Grade ≥ 3 Laboratory Abnormalities | Grade ≥ 3 Laboratory Abnormalities | 4.5 percentage of participants |
Secondary
Percentage of Participants Experiencing Treatment-Emergent Study Drug-related Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs were defined as events that met one of the following criteria: 1) Any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; or 2) Any AEs leading to premature discontinuation of study drug.
Time frame: Day 1 plus 30 days
Population: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Moderate Hepatic Impairment | Percentage of Participants Experiencing Treatment-Emergent Study Drug-related Adverse Events (AEs) | 20.0 percentage of participants |
| Cohort 2: Severe Hepatic Impairment | Percentage of Participants Experiencing Treatment-Emergent Study Drug-related Adverse Events (AEs) | 0 percentage of participants |
| Cohort 3: Mild Hepatic Impairment | Percentage of Participants Experiencing Treatment-Emergent Study Drug-related Adverse Events (AEs) | 10.0 percentage of participants |
| Matched Healthy Control for Cohort 1 | Percentage of Participants Experiencing Treatment-Emergent Study Drug-related Adverse Events (AEs) | 13.6 percentage of participants |