NCT00369304

Brief Summary

This is an open-label, randomized, 2-period crossover, inpatient study to be performed in healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or AGG-523 plus tolbutamide in periods 1 and 2 in a crossover design. Doses of test article will be administered after an overnight fast of at least 10 hours.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_1

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

July 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2006

Completed
Last Updated

August 7, 2009

Status Verified

August 1, 2009

Enrollment Period

1 month

First QC Date

August 25, 2006

Last Update Submit

August 6, 2009

Conditions

Healthy Subjects

Keywords

Health

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effects of a single oral dose of AGG-523 on the pharmacokinetic profile of a single oral dose of tolbutamide in healthy subjects.

Interventions

pharmacokinetic (how the body absorbs and eliminates) interactionDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
1. Men and women, aged 18 to 50 years. Women of non-childbearing potential may be included. 2. Body mass index in the range of 18 to 30 kg/meter squared and body weight equal to or greater than 50 kg. 3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead electrocardiogram (graphic trace of the pattern of your heart beat). 4. Non-smoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined by history. Must abstain from smoking during inpatient stay. 5. Have a high probability for compliance with and completion of the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Interventions

Drug Interactions

Intervention Hierarchy (Ancestors)

Pharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 25, 2006

First Posted

August 29, 2006

Study Start

July 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

August 7, 2009

Record last verified: 2009-08