NCT00842400

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_1 obesity

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

January 21, 2010

Status Verified

January 1, 2010

Enrollment Period

28 days

First QC Date

February 6, 2009

Last Update Submit

January 20, 2010

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

  • The primary endpoints of this study will be the PK parameters AUC0-τ and Cmax of phentermine, topiramate, sitagliptin and metformin.

    40 days

Secondary Outcomes (1)

  • The secondary endpoint is the topiramate concentration in semen.

    40 days

Interventions

Metformin, VI-0521, Sitagliptan, ProbenecidDRUG

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.

Also known as: VI-0521, Sitagliptan, Metformin, Probenecid

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDS Pharma Services

Phoenix, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

MetforminProbenecid

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsSulfonamidesAmidesSulfonesSulfur Compounds

Study Officials

  • Shiyin Yee

    VIVUS LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 12, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

January 21, 2010

Record last verified: 2010-01

Locations

US(1)