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

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ClinicalTrials.gov Identifier: NCT00739232
Recruitment Status : Completed
First Posted : August 21, 2008
Last Update Posted : August 3, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: HSD-016 Other: placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016 Administered Orally to Healthy Subjects
Study Start Date : September 2008
Primary Completion Date : February 2009
Study Completion Date : February 2009
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Active
Active
Drug: HSD-016
Placebo Comparator: Placebo
Placebo
Other: placebo


Outcome Measures

Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Profiles of Drug Concentrations [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739232


Locations
United States, Kansas
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00739232     History of Changes
Other Study ID Numbers: 3248A1-1000
First Posted: August 21, 2008    Key Record Dates
Last Update Posted: August 3, 2009
Last Verified: July 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Safety and tolerability of HSD-016