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

This study has been completed.
Sponsor:
Information provided by:
FibroGen
ClinicalTrials.gov Identifier:
NCT01376063
First received: June 16, 2011
Last updated: June 17, 2011
Last verified: June 2011
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in plasma concentration of Rosiglitazone metabolites [ Time Frame: Day 3 - Day 11 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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

No publications provided

Responsible Party: Robert Leong, MD., Medical Monitor, FibroGen, Inc
ClinicalTrials.gov Identifier: NCT01376063     History of Changes
Other Study ID Numbers: FGCL-4592-037
Study First Received: June 16, 2011
Last Updated: June 17, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 14, 2014