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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00740649
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 14.9

Study Details

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 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 Design

• Study Type: Interventional
• Anticipated 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: Oct 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. clinical labs, adverse events [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00740649
• Other Study ID Numbers: 3248A1-1001
• First Posted: Aug 25, 2008
• Last Update Posted: Mar 31, 2009
• Last Verified: Mar 1, 2009

Study Results

No Results Posted as of Mar 31, 2009