Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016 - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 20, 2008

Last Updated Date

February 5, 2009

Start Date ^†

September 2008

Current Primary Outcome Measures ^†

Safety and Tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00739232 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Profiles of Drug Concentrations [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016

Official Title ^†

Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016 Administered Orally to Healthy Subjects

Brief Summary

This is a single ascending dose study of HSD-016 to provide the initial assessment of the safety, tolerability, how the drug is absorbed and eliminated, and its effect on the body.

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety Study

Condition ^†

Healthy Subjects

Intervention ^†

Drug: HSD-016
Other: placebo

Study Arms / Comparison Groups

Active Comparator: Active
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Estimated Completion Date

March 2009

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion:

Men or women of nonchildbearing potential aged 18 to 50 years inclusive at screening.
Healthy as determined by the investigator on the basis of screening evaluations.
Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion:

No presence or history of any disorder that may prevent the successful completion of the study.
No history of drug abuse within 1 year.

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Trial Manager

clintrialparticipation@wyeth.com

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00739232

Responsible Party

Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth

Secondary IDs ^††

Study Sponsor ^†

Wyeth

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.