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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00838461
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 10.6

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2009
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Levels of drug concentrations will be evaluated after receiving multiple doses of HSD-016 [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00838461
• Other Study ID Numbers: 3248A1-1002
• First Posted: Feb 6, 2009
• Last Update Posted: Aug 3, 2009
• Last Verified: Jul 1, 2009

Study Results

No Results Posted as of Aug 3, 2009