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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01376063
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : June 20, 2011
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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 Type : Interventional  (Clinical Trial)
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 : March 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: FG-4592 Drug: FG-4592

FG-4592 on days 3,5,7,9

Rosiglitazone maleate on days 1 and 9

Primary Outcome Measures :
  1. Change in plasma concentration of Rosiglitazone [ Time Frame: Day 1- Day 11 ]

Secondary Outcome Measures :
  1. Change in plasma concentration of Rosiglitazone metabolites [ Time Frame: Day 3 - Day 11 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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

Responsible Party: Robert Leong, MD., Medical Monitor, FibroGen, Inc Identifier: NCT01376063     History of Changes
Other Study ID Numbers: FGCL-4592-037
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: June 20, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs