Trial record 1 of 1 for: NCT00434785

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A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males

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ClinicalTrials.gov Identifier: NCT00434785

Recruitment Status : Completed

First Posted : February 13, 2007

Last Update Posted : December 5, 2007

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

First Submitted Date ^ICMJE

February 9, 2007

First Posted Date ^ICMJE

February 13, 2007

Last Update Posted Date

December 5, 2007

Study Start Date ^ICMJE

February 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

To assess the safety and PK profile

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males

Official Title ^ICMJE

An Ascending, Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 Administered Orally to Healthy Male Japanese Subjects.

Brief Summary

To assess the safety and tolerability of ascending, multiple oral doses of AGG-523 in healthy Japanese subjects.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: AGG-523

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date ^ICMJE

September 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Men aged 20 to 40 years, inclusive, at screening; sexually active men must agree to use a medically acceptable form of contraception during the study and continue for 12 weeks after test article administration.
Body mass index (BMI) in the range of 17.6 to 26.4 Kgm2, and body weight >45 kg.
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead ECG.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

Male

Ages ^ICMJE

20 Years to 40 Years (Adult)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Japan

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00434785

Other Study ID Numbers ^ICMJE

3189A1-105

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

PRS Account

Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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