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

A Phase 1, Single-Center, One-Sequence, Open-Label Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01376063

Enrollment

Registered

2011-06-20

Start date

2010-03-31

Completion date

2010-06-30

Last updated

2011-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Subjects

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.

Interventions

DRUGFG-4592

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
Change in plasma concentration of Rosiglitazone	Day 1- Day 11

Secondary

Measure	Time frame
Change in plasma concentration of Rosiglitazone metabolites	Day 3 - Day 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026