Study Evaluating the Safety, Pharmacokinetics (PK), and Pharmacodynamices (PD) of HSD-016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00838461
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : August 3, 2009
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
This is intended to provide an initial safety assessment of HSD-016 and also to evaluate how the drug is absorbed and eliminated and its effect on the body in healthy subjects.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of HSD-016 Administered Orally to Healthy Subjects
Study Start Date : March 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
Active Comparator: 1
Drug: HSD-016
Placebo Comparator: 2
Drug: placebo

Primary Outcome Measures :
  1. Safety will be evaluated from reported AEs, scheduled physical, vital sign measurements, 12 lead ECGs, and clinical laboratory test results. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Levels of drug concentrations will be evaluated after receiving multiple doses of HSD-016 [ Time Frame: 3 months ]

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

Inclusion criteria:

  1. Men or women of nonchildbearing potential aged 18 to 50 years.
  2. Healthy as determined by investigator on the basis of medical history and physical examination, laboratory test results, and 12-lead ECG. 3. Nonsmoker or smoker of fewer than 10 cigarettes per day.

Exclusion criteria:

  1. No history of thyroid abnormalities.
  2. No presence or history of any disorder that may prevent the successful completion of the study.
  3. No history of drug abuse.
  4. No use of any systemic steroids for 3 months.
  5. No history of claustrophobia.

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 identifier (NCT number): NCT00838461

United States, California
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth Identifier: NCT00838461     History of Changes
Other Study ID Numbers: 3248A1-1002
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: August 3, 2009
Last Verified: July 2009