Hepatitis B viral infection
Conditions
Interventions
See Protocol and ICF's.
Sponsors
Gilead Sciences, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To evaluate the effect of CYP3A/P-gp/BCRP inhibition on the pharmacokinetics (PK) of GS-4224 • To evaluate the effect of CYP3A/P-gp/BCRP induction on the PK of GS-4224 • To evaluate the effect of GS-4224 on the PK of CYP3A substrates | — |
Secondary
| Measure | Time frame |
|---|---|
| • To evaluate the effect of GS-4224 on GS-9688 PK • To evaluate the safety and tolerability of GS-4224 alone or in combination with probe drugs or GS-9688 | — |
Countries
Netherlands
Outcome results
None listed