Trial Outcomes & Findings for Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function (NCT NCT02891408)
NCT ID: NCT02891408
Last Updated: 2020-12-17
Results Overview
AUClast is defined as the concentration of drug from time zero to the last observable concentration. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
74 participants
Primary outcome timeframe
Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable)
Results posted on
2020-12-17
Participant Flow
Participants were enrolled at study sites in United States. The first participant was screened on 23 September 2016. The last study visit occurred on 13 May 2019.
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. 14 total unique participants with normal hepatic function were enrolled in Cohort 1 (N = 10) and Cohort 2 (N = 4). 6 participants with normal hepatic function from Cohort 1 also served as matched controls in Cohort 2.
Participant milestones
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 & 2 (Normal Hepatic Function): Firsocostat 20 mg
Matched normal hepatic function participants to mild or moderate hepatic impairment participants received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function) Firsocostat 5 mg
Matched normal hepatic function participants to severe hepatic impairment participants received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function) Fenofibrate 48 mg
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
14
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
13
|
10
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 & 2 (Normal Hepatic Function): Firsocostat 20 mg
Matched normal hepatic function participants to mild or moderate hepatic impairment participants received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function) Firsocostat 5 mg
Matched normal hepatic function participants to severe hepatic impairment participants received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function) Fenofibrate 48 mg
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function
Baseline characteristics by cohort
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 & 2 (Normal Hepatic Function): Firsocostat 20 mg
n=14 Participants
Matched normal hepatic function participants to mild or moderate hepatic impairment participants received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
n=10 Participants
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function) Firsocostat 5 mg
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment participants received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function) Fenofibrate 48 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
56 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
55 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
53 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
54 years
STANDARD_DEVIATION 8.4 • n=21 Participants
|
58 years
STANDARD_DEVIATION 6.4 • n=8 Participants
|
58 years
STANDARD_DEVIATION 5.1 • n=8 Participants
|
55 years
STANDARD_DEVIATION 8.0 • n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
52 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
40 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
34 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
57 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable)Population: PK Analysis Sets included all enrolled participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value reported by PK laboratory for corresponding analytes. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2.
AUClast is defined as the concentration of drug from time zero to the last observable concentration. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4).
Outcome measures
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
n=10 Participants
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: AUClast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Fenofibric Acid
|
—
|
—
|
—
|
—
|
—
|
—
|
61207.4 hr*ng/mL
Standard Deviation 24630.23
|
48128.0 hr*ng/mL
Standard Deviation 17377.69
|
|
Pharmacokinetic (PK) Parameter: AUClast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Firsocostat
|
160.6 hr*ng/mL
Standard Deviation 158.28
|
69.8 hr*ng/mL
Standard Deviation 38.73
|
682.1 hr*ng/mL
Standard Deviation 497.09
|
64.5 hr*ng/mL
Standard Deviation 33.22
|
310.4 hr*ng/mL
Standard Deviation 75.18
|
10.2 hr*ng/mL
Standard Deviation 2.92
|
—
|
—
|
|
Pharmacokinetic (PK) Parameter: AUClast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
GS-834773
|
46.2 hr*ng/mL
Standard Deviation 57.67
|
7.4 hr*ng/mL
Standard Deviation 5.83
|
395.8 hr*ng/mL
Standard Deviation 535.93
|
5.1 hr*ng/mL
Standard Deviation 3.21
|
153.3 hr*ng/mL
Standard Deviation 65.72
|
1.4 hr*ng/mL
Standard Deviation 1.38
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable)Population: Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2.
AUCinf is defined as the concentration of drug extrapolated to infinite time. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4).
Outcome measures
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
n=10 Participants
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: AUCinf of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Firsocostat
|
165.2 hr*ng/mL
Standard Deviation 162.71
|
70.5 hr*ng/mL
Standard Deviation 38.82
|
686.6 hr*ng/mL
Standard Deviation 499.35
|
65.8 hr*ng/mL
Standard Deviation 34.36
|
313.6 hr*ng/mL
Standard Deviation 72.68
|
10.6 hr*ng/mL
Standard Deviation 2.97
|
—
|
—
|
|
PK Parameter: AUCinf of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
GS-834773
|
48.5 hr*ng/mL
Standard Deviation 59.21
|
8.2 hr*ng/mL
Standard Deviation 5.84
|
399.0 hr*ng/mL
Standard Deviation 537.09
|
5.9 hr*ng/mL
Standard Deviation 3.46
|
155.9 hr*ng/mL
Standard Deviation 65.85
|
1.6 hr*ng/mL
Standard Deviation 1.37
|
—
|
—
|
|
PK Parameter: AUCinf of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Fenofibric Acid
|
—
|
—
|
—
|
—
|
—
|
—
|
65530.7 hr*ng/mL
Standard Deviation 25917.76
|
50754.1 hr*ng/mL
Standard Deviation 18262.73
|
PRIMARY outcome
Timeframe: Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable)Population: Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2.
Cmax is defined as the maximum observed concentration of drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4).
Outcome measures
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
n=10 Participants
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Cmax of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
GS-834773
|
12.9 ng/mL
Standard Deviation 16.08
|
2.3 ng/mL
Standard Deviation 2.11
|
77.3 ng/mL
Standard Deviation 56.03
|
1.4 ng/mL
Standard Deviation 1.16
|
31.3 ng/mL
Standard Deviation 14.66
|
0.5 ng/mL
Standard Deviation 0.64
|
—
|
—
|
|
PK Parameter: Cmax of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Firsocostat
|
50.9 ng/mL
Standard Deviation 45.96
|
25.4 ng/mL
Standard Deviation 20.44
|
197.7 ng/mL
Standard Deviation 118.67
|
20.1 ng/mL
Standard Deviation 12.09
|
73.8 ng/mL
Standard Deviation 17.70
|
3.0 ng/mL
Standard Deviation 1.56
|
—
|
—
|
|
PK Parameter: Cmax of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Fenofibric Acid
|
—
|
—
|
—
|
—
|
—
|
—
|
2723.0 ng/mL
Standard Deviation 1078.36
|
2451.0 ng/mL
Standard Deviation 808.68
|
PRIMARY outcome
Timeframe: Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable)Population: Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2.
%AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4).
Outcome measures
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
n=10 Participants
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: % AUCexp of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Firsocostat
|
2.54 percentage of AUC
Standard Deviation 2.378
|
1.36 percentage of AUC
Standard Deviation 1.222
|
0.63 percentage of AUC
Standard Deviation 0.788
|
1.92 percentage of AUC
Standard Deviation 1.645
|
1.35 percentage of AUC
Standard Deviation 1.953
|
4.68 percentage of AUC
Standard Deviation 2.671
|
—
|
—
|
|
PK Parameter: % AUCexp of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
GS-834773
|
7.16 percentage of AUC
Standard Deviation 7.997
|
13.16 percentage of AUC
Standard Deviation 12.642
|
1.71 percentage of AUC
Standard Deviation 1.889
|
13.59 percentage of AUC
Standard Deviation 12.288
|
2.21 percentage of AUC
Standard Deviation 2.288
|
25.94 percentage of AUC
Standard Deviation 19.497
|
—
|
—
|
|
PK Parameter: % AUCexp of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Fenofibric Acid
|
—
|
—
|
—
|
—
|
—
|
—
|
7.11 percentage of AUC
Standard Deviation 3.767
|
5.38 percentage of AUC
Standard Deviation 2.758
|
PRIMARY outcome
Timeframe: Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable)Population: Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2.
Tmax is defined as the time (observed time point) of Cmax. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4).
Outcome measures
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
n=10 Participants
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Tmax of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Firsocostat
|
1.00 hours
Interval 1.0 to 2.0
|
1.00 hours
Interval 1.0 to 2.0
|
1.00 hours
Interval 1.0 to 1.02
|
1.00 hours
Interval 1.0 to 2.0
|
1.50 hours
Interval 1.0 to 2.0
|
2.50 hours
Interval 1.0 to 3.0
|
—
|
—
|
|
PK Parameter: Tmax of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
GS-834773
|
1.50 hours
Interval 1.0 to 2.0
|
1.00 hours
Interval 1.0 to 3.0
|
1.00 hours
Interval 1.0 to 1.02
|
1.50 hours
Interval 1.0 to 2.0
|
2.00 hours
Interval 2.0 to 2.0
|
2.50 hours
Interval 1.0 to 3.0
|
—
|
—
|
|
PK Parameter: Tmax of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Fenofibric Acid
|
—
|
—
|
—
|
—
|
—
|
—
|
3.00 hours
Interval 3.0 to 4.0
|
2.50 hours
Interval 2.0 to 3.0
|
PRIMARY outcome
Timeframe: Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable)Population: Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2.
Clast is defined as the last observed quantifiable concentration of drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4).
Outcome measures
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
n=10 Participants
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Clast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Firsocostat
|
0.20 ng/mL
Standard Deviation 0.114
|
0.10 ng/mL
Standard Deviation 0.042
|
0.26 ng/mL
Standard Deviation 0.359
|
0.10 ng/mL
Standard Deviation 0.047
|
0.23 ng/mL
Standard Deviation 0.204
|
0.08 ng/mL
Standard Deviation 0.017
|
—
|
—
|
|
PK Parameter: Clast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
GS-834773
|
0.11 ng/mL
Standard Deviation 0.051
|
0.12 ng/mL
Standard Deviation 0.070
|
0.18 ng/mL
Standard Deviation 0.104
|
0.11 ng/mL
Standard Deviation 0.077
|
0.22 ng/mL
Standard Deviation 0.185
|
0.07 ng/mL
Standard Deviation 0.027
|
—
|
—
|
|
PK Parameter: Clast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Fenofibric Acid
|
—
|
—
|
—
|
—
|
—
|
—
|
133.04 ng/mL
Standard Deviation 51.253
|
90.71 ng/mL
Standard Deviation 33.405
|
PRIMARY outcome
Timeframe: Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable)Population: Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2.
Tlast is defined as the time (observed time point) of Clast. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4).
Outcome measures
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
n=10 Participants
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Tlast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Fenofibric Acid
|
—
|
—
|
—
|
—
|
—
|
—
|
96.00 hours
Interval 72.0 to 96.17
|
84.25 hours
Interval 72.0 to 96.0
|
|
PK Parameter: Tlast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Firsocostat
|
24.00 hours
Interval 24.0 to 72.0
|
24.00 hours
Interval 24.0 to 24.0
|
72.00 hours
Interval 48.0 to 96.0
|
24.00 hours
Interval 24.0 to 48.0
|
48.00 hours
Interval 47.97 to 72.0
|
16.00 hours
Interval 12.0 to 16.0
|
—
|
—
|
|
PK Parameter: Tlast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
GS-834773
|
24.00 hours
Interval 16.0 to 72.0
|
12.00 hours
Interval 10.0 to 16.0
|
48.02 hours
Interval 24.0 to 96.0
|
11.00 hours
Interval 10.0 to 16.0
|
36.04 hours
Interval 24.0 to 48.0
|
7.00 hours
Interval 6.0 to 8.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable)Population: Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2.
λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4).
Outcome measures
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
n=10 Participants
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: λz of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Firsocostat
|
0.132 1/hour
Standard Deviation 0.1093
|
0.155 1/hour
Standard Deviation 0.0684
|
0.096 1/hour
Standard Deviation 0.0753
|
0.136 1/hour
Standard Deviation 0.0796
|
0.077 1/hour
Standard Deviation 0.0204
|
0.193 1/hour
Standard Deviation 0.0765
|
—
|
—
|
|
PK Parameter: λz of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
GS-834773
|
0.133 1/hour
Standard Deviation 0.0948
|
0.214 1/hour
Standard Deviation 0.0942
|
0.105 1/hour
Standard Deviation 0.0916
|
0.209 1/hour
Standard Deviation 0.0918
|
0.103 1/hour
Standard Deviation 0.0543
|
0.300 1/hour
Standard Deviation 0.1379
|
—
|
—
|
|
PK Parameter: λz of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Fenofibric Acid
|
—
|
—
|
—
|
—
|
—
|
—
|
0.034 1/hour
Standard Deviation 0.0080
|
0.038 1/hour
Standard Deviation 0.0082
|
PRIMARY outcome
Timeframe: Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable)Population: Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2.
CL/F is defined as the apparent oral clearance following administration of the drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4).
Outcome measures
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
n=10 Participants
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: CL/F of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Firsocostat
|
259318.9 mL/hour
Standard Deviation 239527.46
|
376896.2 mL/hour
Standard Deviation 228676.47
|
59482.2 mL/hour
Standard Deviation 63193.83
|
395572.3 mL/hour
Standard Deviation 226508.90
|
16969.7 mL/hour
Standard Deviation 5154.88
|
509793.4 mL/hour
Standard Deviation 168681.93
|
—
|
—
|
|
PK Parameter: CL/F of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
GS-834773
|
1467352.6 mL/hour
Standard Deviation 1790413.18
|
3966285.6 mL/hour
Standard Deviation 2982349.95
|
239748.5 mL/hour
Standard Deviation 351882.41
|
4795605.6 mL/hour
Standard Deviation 2952570.14
|
44379.6 mL/hour
Standard Deviation 38793.78
|
4656562.3 mL/hour
Standard Deviation 2689827.70
|
—
|
—
|
|
PK Parameter: CL/F of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Fenofibric Acid
|
—
|
—
|
—
|
—
|
—
|
—
|
909.4 mL/hour
Standard Deviation 539.09
|
1060.8 mL/hour
Standard Deviation 391.86
|
PRIMARY outcome
Timeframe: Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable)Population: Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2.
Vz/F is defined as the apparent volume of distribution of the drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4).
Outcome measures
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
n=10 Participants
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Vz/F of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Fenofibric Acid
|
—
|
—
|
—
|
—
|
—
|
—
|
25908.5 mL
Standard Deviation 9331.48
|
28290.3 mL
Standard Deviation 8476.01
|
|
PK Parameter: Vz/F of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Firsocostat
|
2896998.5 mL
Standard Deviation 2176020.23
|
2846198.8 mL
Standard Deviation 2249997.50
|
592810.8 mL
Standard Deviation 318935.52
|
3797739.4 mL
Standard Deviation 2684509.46
|
230242.5 mL
Standard Deviation 92293.34
|
3079474.8 mL
Standard Deviation 1593778.35
|
—
|
—
|
|
PK Parameter: Vz/F of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
GS-834773
|
15576712.2 mL
Standard Deviation 19451521.66
|
19236747.1 mL
Standard Deviation 10816737.06
|
2126366.5 mL
Standard Deviation 2117217.85
|
23635388.6 mL
Standard Deviation 10179635.17
|
501512.3 mL
Standard Deviation 524040.62
|
20312673.6 mL
Standard Deviation 18230756.23
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: 0 (predose, ≤ 5 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose; or 72 hours of early termination from the study (if applicable)Population: Participants in the PK Analysis Sets were analyzed. 6 participants with normal hepatic function served as matched controls across both Cohort 1 and 2.
t1/2 is defined as the estimate of the terminal elimination half-life of the drug. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4).
Outcome measures
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
n=10 Participants
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: t1/2 of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
GS-834773
|
5.24 hours
Interval 3.44 to 25.28
|
3.32 hours
Interval 2.58 to 3.97
|
12.82 hours
Interval 4.13 to 17.25
|
3.28 hours
Interval 2.88 to 3.85
|
8.51 hours
Interval 6.84 to 9.19
|
2.49 hours
Interval 1.78 to 3.51
|
—
|
—
|
|
PK Parameter: t1/2 of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Firsocostat
|
5.23 hours
Interval 3.91 to 25.19
|
4.39 hours
Interval 3.73 to 6.78
|
11.20 hours
Interval 6.57 to 13.56
|
5.04 hours
Interval 4.0 to 11.02
|
9.54 hours
Interval 7.89 to 10.79
|
3.93 hours
Interval 2.55 to 4.93
|
—
|
—
|
|
PK Parameter: t1/2 of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)
Fenofibric Acid
|
—
|
—
|
—
|
—
|
—
|
—
|
21.33 hours
Interval 17.9 to 26.43
|
18.27 hours
Interval 15.73 to 21.34
|
SECONDARY outcome
Timeframe: First dose date plus 30 daysPopulation: Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
Treatment-emergent adverse events (TEAEs) were defined as 1 or both of the following: * Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug. If the AE onset date is the same as the date of study drug start date then the AE onset time must be on or after the study drug start time. If the AE onset time is missing when the start dates are the same, the AE will be considered treatment emergent. * Any AEs leading to premature discontinuation of study drug.
Outcome measures
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
n=14 Participants
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
n=10 Participants
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
|
20.0 percentage of participants
|
10.0 percentage of participants
|
7.1 percentage of participants
|
30.0 percentage of participants
|
10.0 percentage of participants
|
0 percentage of participants
|
10.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: First dose date plus 30 daysPopulation: Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
Treatment-emergent laboratory abnormalities are defined as values that increase 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 subjects who permanently discontinued study drug. The most severe graded abnormality from all tests was counted for each participant.
Outcome measures
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
n=14 Participants
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Normal Hepatic Function): Firsocostat 20 mg
n=10 Participants
Matched normal hepatic function participants to moderate hepatic impairment participants, received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
n=10 Participants
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function): Firsocostat 5 mg
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment participants, received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
n=10 Participants
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function): Fenofibrate 48 mg
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Laboratory Abnormalities
|
100.0 Percentage of participants
|
90.0 Percentage of participants
|
50.0 Percentage of participants
|
100.0 Percentage of participants
|
50.0 Percentage of participants
|
90.0 Percentage of participants
|
60.0 Percentage of participants
|
—
|
Adverse Events
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1 & 2 (Normal Hepatic Function): Firsocostat 20 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3 (Normal Hepatic Function) Firsocostat 5 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4 (Normal Hepatic Function) Fenofibrate 48 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 (Mild Hepatic Impairment): Firsocostat 20 mg
n=10 participants at risk
Participants with mild hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 2 (Moderate Hepatic Impairment): Firsocostat 20 mg
n=10 participants at risk
Participants with moderate hepatic impairment received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1.
|
Cohort 1 & 2 (Normal Hepatic Function): Firsocostat 20 mg
n=14 participants at risk
Matched normal hepatic function participants to mild or moderate hepatic impairment participants received a single dose of firsocostat 20 mg (2 × 10 mg capsules) orally on Day 1
|
Cohort 3 (Severe Hepatic Impairment): Firsocostat 5 mg
n=10 participants at risk
Participants with severe hepatic impairment received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 3 (Normal Hepatic Function) Firsocostat 5 mg
n=10 participants at risk
Matched normal hepatic function participants to severe hepatic impairment participants received a single dose of firsocostat 5 mg (1 × 5 mg capsule) orally on Day 1.
|
Cohort 4 (Mild Hepatic Impairment): Fenofibrate 48 mg
n=10 participants at risk
Participants with mild hepatic impairment received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
Cohort 4 (Normal Hepatic Function) Fenofibrate 48 mg
n=10 participants at risk
Matched normal hepatic function participants to mild hepatic impairment participants, received a single dose of fenofibrate 48 mg (1 × 48 mg tablet) orally on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/14 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
10.0%
1/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
10.0%
1/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/14 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
10.0%
1/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
7.1%
1/14 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
|
Investigations
Amylase increased
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/14 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
10.0%
1/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
10.0%
1/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
7.1%
1/14 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/14 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
10.0%
1/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
|
Vascular disorders
Flushing
|
10.0%
1/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/14 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
0.00%
0/10 • First dose date plus 30 days
Participants in the Safety Analysis Set were analyzed. 6 participants served as matched control across both Cohort 1 and 2.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER