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
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2010
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 16, 2011
CompletedFirst Posted
Study publicly available on registry
June 20, 2011
CompletedJune 20, 2011
June 1, 2011
2 months
June 16, 2011
June 17, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change in plasma concentration of Rosiglitazone
Day 1- Day 11
Secondary Outcomes (1)
Change in plasma concentration of Rosiglitazone metabolites
Day 3 - Day 11
Study Arms (1)
FG-4592
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy adult males, 18 to 45 years
- Body weight ≥ 75 kg
- Good health
- Non-smoker
- Blood pressure not greater than 140/90 mm Hg
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyntra Biolead
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 16, 2011
First Posted
June 20, 2011
Study Start
March 1, 2010
Primary Completion
May 1, 2010
Study Completion
June 1, 2010
Last Updated
June 20, 2011
Record last verified: 2011-06