Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects

FibroGen

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Subjects

Treatments: Drug: FG-4592

Study type: Interventional

Funder types: Industry

Identifiers

NCT01376063

FGCL-4592-037

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 1 patient group

FG-4592

Experimental group

Treatment:

Drug: FG-4592