Trial Outcomes & Findings for Study to Evaluate the Pharmacokinetics of Selonsertib in Participants With Normal and Impaired Hepatic Function (NCT NCT02509624)
NCT ID: NCT02509624
Last Updated: 2021-01-27
Results Overview
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
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.
Results posted on
2021-01-27
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
22
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Pharmacokinetics of Selonsertib in Participants With Normal and Impaired Hepatic Function
Baseline characteristics by cohort
| Measure |
Cohort 1: Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Cohort 2: Severe Hepatic Impairment
n=10 Participants
Participants with severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Cohort 3: Mild Hepatic Impairment
n=10 Participants
Participants with mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Healthy Control
n=22 Participants
Matched normal hepatic function participants received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
54 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
53 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
53 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
54 years
STANDARD_DEVIATION 7.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
25 Participants
n=21 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
40 Participants
n=21 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
|
|
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
|
PRIMARY outcome
Timeframe: 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.
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Outcome measures
| Measure |
Cohort 1: Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Cohort 2: Severe Hepatic Impairment
n=10 Participants
Participants with severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Cohort 3: Mild Hepatic Impairment
n=10 Participants
Participants with mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Matched Healthy Control for Cohort 1
n=10 Participants
Matched normal hepatic function participants to moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Matched Healthy Control for Cohort 2
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Matched Healthy Control for Cohort 3
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509
AUCinf of Selonsertib
|
3316.1 hr*ng/mL
Standard Deviation 1734.11
|
3266.7 hr*ng/mL
Standard Deviation 766.39
|
2962.1 hr*ng/mL
Standard Deviation 901.12
|
2835.3 hr*ng/mL
Standard Deviation 499.58
|
2277.9 hr*ng/mL
Standard Deviation 490.96
|
2711.6 hr*ng/mL
Standard Deviation 919.83
|
|
Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509
AUCinf of GS-607509
|
5941.8 hr*ng/mL
Standard Deviation 2286.80
|
5711.2 hr*ng/mL
Standard Deviation 3401.94
|
10203.6 hr*ng/mL
Standard Deviation 8689.39
|
9993.3 hr*ng/mL
Standard Deviation 4599.91
|
9603.4 hr*ng/mL
Standard Deviation 8057.84
|
9846.6 hr*ng/mL
Standard Deviation 8954.40
|
PRIMARY outcome
Timeframe: 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.
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Outcome measures
| Measure |
Cohort 1: Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Cohort 2: Severe Hepatic Impairment
n=10 Participants
Participants with severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Cohort 3: Mild Hepatic Impairment
n=10 Participants
Participants with mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Matched Healthy Control for Cohort 1
n=10 Participants
Matched normal hepatic function participants to moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Matched Healthy Control for Cohort 2
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Matched Healthy Control for Cohort 3
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
|---|---|---|---|---|---|---|
|
PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509
AUClast of GS-607509
|
5405.2 hr*ng/mL
Standard Deviation 2211.86
|
4868.0 hr*ng/mL
Standard Deviation 3072.43
|
8475.8 hr*ng/mL
Standard Deviation 7165.86
|
9117.6 hr*ng/mL
Standard Deviation 4127.22
|
8157.5 hr*ng/mL
Standard Deviation 6019.61
|
8326.5 hr*ng/mL
Standard Deviation 6604.26
|
|
PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509
AUClast of Selonsertib
|
2964.1 hr*ng/mL
Standard Deviation 1493.69
|
3032.7 hr*ng/mL
Standard Deviation 728.55
|
2790.8 hr*ng/mL
Standard Deviation 847.18
|
2679.9 hr*ng/mL
Standard Deviation 486.23
|
2129.7 hr*ng/mL
Standard Deviation 493.83
|
2530.9 hr*ng/mL
Standard Deviation 902.55
|
PRIMARY outcome
Timeframe: 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.
Cmax is defined as the maximum concentration of drug.
Outcome measures
| Measure |
Cohort 1: Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Cohort 2: Severe Hepatic Impairment
n=10 Participants
Participants with severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Cohort 3: Mild Hepatic Impairment
n=10 Participants
Participants with mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Matched Healthy Control for Cohort 1
n=10 Participants
Matched normal hepatic function participants to moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Matched Healthy Control for Cohort 2
n=10 Participants
Matched normal hepatic function participants to severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Matched Healthy Control for Cohort 3
n=10 Participants
Matched normal hepatic function participants to mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
|---|---|---|---|---|---|---|
|
PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509
Cmax of Selonsertib
|
93.7 ng/mL
Standard Deviation 20.66
|
82.4 ng/mL
Standard Deviation 10.63
|
110.6 ng/mL
Standard Deviation 24.77
|
105.4 ng/mL
Standard Deviation 22.13
|
91.9 ng/mL
Standard Deviation 22.01
|
110.3 ng/mL
Standard Deviation 23.40
|
|
PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509
Cmax of GS-607509
|
44.1 ng/mL
Standard Deviation 15.01
|
31.2 ng/mL
Standard Deviation 15.34
|
63.5 ng/mL
Standard Deviation 31.42
|
62.3 ng/mL
Standard Deviation 23.44
|
63.2 ng/mL
Standard Deviation 27.03
|
64.2 ng/mL
Standard Deviation 21.99
|
SECONDARY outcome
Timeframe: Day 1 plus 30 daysPopulation: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Cohort 1: Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Cohort 2: Severe Hepatic Impairment
n=10 Participants
Participants with severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Cohort 3: Mild Hepatic Impairment
n=10 Participants
Participants with mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Matched Healthy Control for Cohort 1
n=22 Participants
Matched normal hepatic function participants to moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Matched Healthy Control for Cohort 2
Matched normal hepatic function participants to severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Matched Healthy Control for Cohort 3
Matched normal hepatic function participants to mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Study Drug-related Adverse Events (AEs)
|
20.0 percentage of participants
|
0 percentage of participants
|
10.0 percentage of participants
|
13.6 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 plus 30 daysPopulation: Participants in the Safety Analysis Set were analyzed.
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.
Outcome measures
| Measure |
Cohort 1: Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Cohort 2: Severe Hepatic Impairment
n=10 Participants
Participants with severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Cohort 3: Mild Hepatic Impairment
n=10 Participants
Participants with mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Matched Healthy Control for Cohort 1
n=22 Participants
Matched normal hepatic function participants to moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Matched Healthy Control for Cohort 2
Matched normal hepatic function participants to severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Matched Healthy Control for Cohort 3
Matched normal hepatic function participants to mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Any Treatment-Emergent and Grade ≥ 3 Laboratory Abnormalities
Grade ≥ 3 Laboratory Abnormalities
|
20.0 percentage of participants
|
40.0 percentage of participants
|
10.0 percentage of participants
|
4.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Experiencing Any Treatment-Emergent and Grade ≥ 3 Laboratory Abnormalities
Any Treatment-Emergent Laboratory Abnormalities
|
90.0 percentage of participants
|
90.0 percentage of participants
|
70.0 percentage of participants
|
59.1 percentage of participants
|
—
|
—
|
Adverse Events
Cohort 1: Moderate Hepatic Impairment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: Severe Hepatic Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3: Mild Hepatic Impairment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Healthy Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: Moderate Hepatic Impairment
n=10 participants at risk
Participants with moderate hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Cohort 2: Severe Hepatic Impairment
n=10 participants at risk
Participants with severe hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Cohort 3: Mild Hepatic Impairment
n=10 participants at risk
Participants with mild hepatic impairment received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
Healthy Control
n=22 participants at risk
Matched normal hepatic function participants received a single oral dose of selonsertib 6 mg (1 × 6 mg tablet) in fed state on Day 1.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Day 1 plus 30 days
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Day 1 plus 30 days
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Day 1 plus 30 days
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Day 1 plus 30 days
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
1/10 • Day 1 plus 30 days
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Day 1 plus 30 days
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Day 1 plus 30 days
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Day 1 plus 30 days
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/10 • Day 1 plus 30 days
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Day 1 plus 30 days
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Day 1 plus 30 days
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Day 1 plus 30 days
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Day 1 plus 30 days
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Day 1 plus 30 days
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Day 1 plus 30 days
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Day 1 plus 30 days
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
|
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