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
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, see Learn About Clinical Studies.

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 September 18, 2014