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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01376063
First Posted: June 20, 2011
Last Update Posted: June 20, 2011
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.
Information provided by:
FibroGen
  Purpose
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 Intervention Phase
Healthy Adult Subjects Drug: FG-4592 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by FibroGen:

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

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

Enrollment: 20
Study Start Date: March 2010
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FG-4592 Drug: FG-4592

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

Rosiglitazone maleate on days 1 and 9


  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
No Contacts or Locations Provided
  More Information

Responsible Party: Robert Leong, MD., Medical Monitor, FibroGen, Inc
ClinicalTrials.gov Identifier: NCT01376063     History of Changes
Other Study ID Numbers: FGCL-4592-037
First Submitted: June 16, 2011
First Posted: June 20, 2011
Last Update Posted: June 20, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs