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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00838461
First Posted: February 6, 2009
Last Update Posted: August 3, 2009
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.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
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 Intervention Phase
Healthy Subjects Drug: HSD-016 Drug: placebo Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Estimated Enrollment: 32
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
HSD-016
Drug: HSD-016
Placebo Comparator: 2
placebo
Drug: placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  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): NCT00838461


Locations
United States, California
Chula Vista, California, United States, 91911
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: NCT00838461     History of Changes
Other Study ID Numbers: 3248A1-1002
First Submitted: February 5, 2009
First Posted: February 6, 2009
Last Update Posted: August 3, 2009
Last Verified: July 2009