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

A Phase 1, Single-Center, One-Sequence, Open-Label Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adult Subjects
• Intervention / Treatment: Drug: FG-4592

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FG-4592	Drug: FG-4592; FG-4592 on days 3,5,7,9 Rosiglitazone maleate on days 1 and 9

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in plasma concentration of Rosiglitazone	Day 1- Day 11

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in plasma concentration of Rosiglitazone metabolites	Day 3 - Day 11

Collaborators and Investigators

• Sponsor: FibroGen

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: June 16, 2011
• First Submitted That Met QC Criteria: June 17, 2011
• First Posted (Estimate): June 20, 2011

Study Record Updates

• Last Update Posted (Estimate): June 20, 2011
• Last Update Submitted That Met QC Criteria: June 17, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: FGCL-4592-037