A Phase 1 Study to Evaluate the Potential Drug-Drug Interaction between GS-4224 and Probe Inhibitors, Inducers and Substrates in Healthy Subjects

Completed

Conditions: Hepatitis B
viral infection
10019654

Registration Number: NL-OMON49788

Lead Sponsor: Gilead Sciences, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 94

Inclusion Criteria

1) Have the ability to understand and sign a written informed consent form
(ICF), which must be obtained prior to initiation of study procedures
2) Be aged 18 through 45 years of age, inclusive at screening
3) Be a nonsmoker. The use of nicotine or nicotine-containing products must be
discontinued 90 days prior to the first dose of study drug.
4) Have a calculated body mass index (BMI) of >= 19.0 and <= 30.0 kg/m2 at
screening
Further criteria apply.

Exclusion Criteria

1) Pregnant or lactating female
2) Received any study drug within 60 days prior to study dosing
3) Current alcohol or substance abuse judged by the investigator to potentially
interfere with subject compliance or subject safety, or a positive drug or
alcohol test at screening or baseline
4) A positive test result for human immunodeficiency virus type 1 (HIV-1)
antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
antibody at screening
a) Subjects who are HCV Ab positive, but have a documented negative HCV RNA,
are eligible
5) Have a positive test result for autoantibodies (ANA >1:80 and/or SMA >1:80
and/or AMA>1:40 and/or anti-TPO >1:40; or lab equivalent for positivity)
Further criteria apply.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• To evaluate the effect of CYP3A/P-gp/BCRP inhibition on the pharmacokinetics<br /><br>(PK) of GS-4224<br /><br>• To evaluate the effect of CYP3A/P-gp/BCRP induction on the PK of GS-4224<br /><br>• To evaluate the effect of GS-4224 on the PK of CYP3A substrates</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To evaluate the effect of GS-4224 on GS-9688 PK<br /><br>• To evaluate the safety and tolerability of GS-4224 alone or in combination<br /><br>with probe drugs or GS-9688</p><br>