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Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of HSD-016

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ClinicalTrials.gov Identifier: NCT00740649
Recruitment Status : Completed
First Posted : August 25, 2008
Last Update Posted : March 31, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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 it's effect on the body in Japanese male subjects.

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

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 Japanese Male Subjects
Study Start Date : October 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Experimental: 1
HSD-016
Drug: HSD-016
2
placebo
Drug: placebo



Primary Outcome Measures :
  1. clinical labs, adverse events [ Time Frame: 6 months ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  1. Men, aged 20 to 45 years inclusive at screening.
  2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg
  3. Healthy as determined by the investigator on the basis of screening evaluations.
  4. 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.

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): NCT00740649


Locations
Japan
Toshima-ku, Tokyo, Japan, 171-0014
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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00740649     History of Changes
Other Study ID Numbers: 3248A1-1001
First Posted: August 25, 2008    Key Record Dates
Last Update Posted: March 31, 2009
Last Verified: March 2009