NCT00369304

CompletedPhase 1

Study Evaluating the Pharmacokinetics of the Potential Drug ...

Wyeth is now a wholly owned subsidiary of Pfizer Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

3189A1-103

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

0 countries

Sites

N/A

Timeline

Study Start

July 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2006

Actual (reported)

Study Completion

August 2006

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): Not reported
Study completion date: August 2006
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2006
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
August 2006
Actual (reported)
Study Completion
August 2006
Actual (reported)
First Submitted
August 25, 2006
Actual (reported)
First Posted
August 29, 2006
Actual (reported)

Last Updated: August 7, 2009
Status Verified: August 2009
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Wyeth is now a wholly owned subsidiary of Pfizer
Industrylead

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 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2006

Actual (reported)

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Study Completion

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Actual (reported)

Last Updated

August 7, 2009

Record last verified: 2009-08

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00369304
Data provider: ClinicalTrials.gov
Source updated: 2009-08-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:32 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record