Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00739232
First received: August 20, 2008
Last updated: July 31, 2009
Last verified: July 2009
History of Changes

August 20, 2008
July 31, 2009
September 2008
February 2009   (final data collection date for primary outcome measure)
Safety and Tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00739232 on ClinicalTrials.gov Archive Site
Profiles of Drug Concentrations [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016
Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016 Administered Orally to Healthy Subjects

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy Subjects
  • Drug: HSD-016
  • Other: placebo
  • Active Comparator: Active
    Active
    Intervention: Drug: HSD-016
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion:

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

Exclusion:

  1. No presence or history of any disorder that may prevent the successful completion of the study.
  2. No history of drug abuse within 1 year.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00739232
3248A1-1000
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2009

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