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

This study is not yet open for participant recruitment.

Verified by Wyeth, August 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00739232

Purpose

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.

Condition	Intervention	Phase
Healthy Subjects	Drug: HSD-016 Other: placebo	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety Study
Official Title:	Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016 Administered Orally to Healthy Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	74
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Active Comparator Active	Drug: HSD-016
Placebo: Placebo Comparator Placebo	Other: placebo

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739232

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3248A1-1000
Study First Received:	August 20, 2008
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00739232
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Safety and tolerability of HSD-016

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009