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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics

NCT00067951

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Effect of Rosiglitazone in Nondiabetic Patients With the Metabolic Syndrome

NCT00364221

Metabolic Syndrome Insulin Resistance

COMPLETED PHASE4

Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

NCT00361868

Dyslipidemia Glucose Metabolism Disorder

TERMINATED PHASE3

Effect of Rosiglitazone on the Vascular Biology of Human Fat Tissue

NCT01150981

Metabolic Syndrome Insulin Resistance

COMPLETED PHASE2

RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes

NCT00379769

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Adult Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FG-4592

Group Type EXPERIMENTAL

FG-4592

Intervention Type DRUG

FG-4592 on days 3,5,7,9

Rosiglitazone maleate on days 1 and 9

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FG-4592

FG-4592 on days 3,5,7,9

Rosiglitazone maleate on days 1 and 9

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes