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

Healthy Adult Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376063
• Other study ID #: FGCL-4592-037
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2011
• Last updated: June 17, 2011
• Start date: March 2010
• Est. completion date: June 2010

Study information

• Verified date: June 2011
• Source: FibroGen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Drug:
• FG-4592
FG-4592 on days 3,5,7,9 Rosiglitazone maleate on days 1 and 9

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
FibroGen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma concentration of Rosiglitazone		Day 1- Day 11	No
Secondary	Change in plasma concentration of Rosiglitazone metabolites		Day 3 - Day 11	No