NL-OMON49788
Completed
Not Applicable
A Phase 1 Study to Evaluate the Potential Drug-Drug Interaction between GS-4224 and Probe Inhibitors, Inducers and Substrates in Healthy Subjects - GS-US-439-5302 DDI study in healthy subjects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatitis B
- Sponsor
- Gilead Sciences, Inc.
- Enrollment
- 94
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Not specified
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