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

• Sponsor: FibroGen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01376063
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Duration (Months): 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Adult Subjects	Drug: FG-4592	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Single-Center, One-Sequence, Open-Label Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in plasma concentration of Rosiglitazone [Day 1- Day 11]

Secondary Outcome Measures

1. Change in plasma concentration of Rosiglitazone metabolites [Day 3 - Day 11]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• FibroGen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01376063
• Other Study ID Numbers: FGCL-4592-037
• First Posted: Jun 20, 2011
• Last Update Posted: Jun 20, 2011
• Last Verified: Jun 1, 2011

Study Results

No Results Posted as of Jun 20, 2011