Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects
- Registration Number
- NCT01376063
- Lead Sponsor
- FibroGen
- Brief Summary
The primary purpose of this study is to assess the effect of multiple doses of FG-4592 on the plasma pharmacokinetic of rosiglitazone in healthy adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria
- Healthy adult males, 18 to 45 years
- Body weight ≥ 75 kg
- Good health
- Non-smoker
- Blood pressure not greater than 140/90 mm Hg
Exclusion Criteria
- Positive for any of the following: Human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab)
- Blood donation or significant blood loss within 60 days prior to Day 1
- Use of prescription and over the counter medications/herbal preparations is not allowed within 14 days prior to Day 1 and through treatment phase
- History or presence of alcoholism or drug abuse within 2 years prior to Day 1
- Consumption of alcohol within 7 days prior to Day 1 or during treatment phase
- Positive urine drug/alcohol testing at screening or check-in visit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FG-4592 FG-4592 -
- Primary Outcome Measures
Name Time Method Change in plasma concentration of Rosiglitazone Day 1- Day 11
- Secondary Outcome Measures
Name Time Method Change in plasma concentration of Rosiglitazone metabolites Day 3 - Day 11