A Drug Interaction Study of VI-0521 With Metformin, Sitagliptan and Probenecid in Healthy 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

2009-02-28

Study Completion Date

2009-04-30

Brief Summary

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

The purposes of this study are to:

* Find out how much of the study drugs are in the blood of healthy subjects after taking multiple doses of VI-0521, metformin and sitagliptan.
* Determine the effect of probenecid on the amount of VI-0521 in the blood of healthy subjects after taking multiple doses.
* Find out how much topiramate is in the semen of healthy male subjects after taking multiple doses.

Related Clinical Trials

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

Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults

NCT00737633

Diabetes

TERMINATED PHASE2

A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults

NCT00600067

Diabetes

COMPLETED PHASE2

A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults

NCT00563368

Obesity

COMPLETED PHASE3

Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults

NCT00554216

Obesity

COMPLETED PHASE3

A Study to Evaluate the Pharmacokinetics of VI-0521 Subjects With Renal Impairment

NCT00768404

Renal Impairment

COMPLETED PHASE1

Detailed Description

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

This trial is an open-label, non-randomized, one-sequence crossover study. All subjects will receive an oral dose of metformin 500 mg tablet twice daily on Days 1 to 5 and on Days 30 to 34; an oral dose of sitagliptin 100 mg tablet once daily on Days 6 to 10 and on Days 35 to 39 and a single oral dose of VI-0521 (phentermine/topiramate) capsule once daily each morning at 3.75/23 mg for 2 days (Days 11-12), 7.5/46 mg for 3 days (Days 13-15), 11.25/69 mg for 3 days (Days 16-18) and 15/92 mg for 21 days (Days 19-39) plus a single oral dose of 2 g (four 500 mg) probenecid tablets on Day 29.

Subjects will remain at the site for the duration of the study (from Day -1 to Day 40). Blood samples for the determination of metformin concentrations in plasma will be collected at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours after the morning administration of metformin or metformin plus VI-0521 on Days 5 and 34. Blood samples for the determination of sitagliptin concentrations in plasma will be collected at 0 (pre-dose), 1, 2, 3, 4, 5, 7, 10, 16 and 24 hours after the administration of sitagliptin or sitagliptin plus VI-0521 on Days 10 and 39. Blood samples for the determination of phentermine and topiramate concentrations in plasma will be collected at 0 (pre-dose), 1, 2, 3, 4, 5, 7, 10, 16 and 24 hours after the administration of the investigational product(s) on Days 28, 29, 34 and 39. Pre-dose blood samples for determination of the investigational drug concentrations in plasma will be taken in the morning on Days 4 and 33 for metformin; Days 9 and 38 for sitagliptin and Days 27, 33 and 38 for phentermine and topiramate. Semen samples for determination of topiramate concentrations will be collected on Day 28 between five and seven hours after VI-0521 administration in 8 male non-vasectomized subjects to obtain at least 6 evaluable subjects.

The primary endpoints of this study will be the PK parameters AUC0-τ and Cmax of phentermine, topiramate, sitagliptin and metformin.The secondary endpoint is the topiramate concentration in semen.

Conditions

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

Obesity

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

CROSSOVER

Blinding Strategy

NONE

Interventions

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

Metformin, VI-0521, Sitagliptan, Probenecid

This trial is an open-label, non-randomized, one-sequence crossover study.

* metformin 500 mg tablet twice daily on Days 1 to 5 and on Days 30 to 34
* sitagliptan 100 mg tablet once daily on Days 6 to 10 and on Days 35 to 39
* VI-0521 (phentermine/topiramate) capsule once daily each morning at 3.75/23 mg for 2 days (Days 11-12), 7.5/46 mg for 3 days (Days 13-15), 11.25/69 mg for 3 days (Days 16-18) and 15/92 mg for 21 days (Days 19-39)
* 2 g (four 500 mg) probenecid tablets on Day 29.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

VI-0521, Sitagliptan, Metformin, Probenecid

Eligibility Criteria

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

Inclusion Criteria

* The study population will consist of adult healthy males or females, 19-45 years of age; inclusive who are medically healthy with no clinically significant screening results.

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes