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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: placebo; Drug: HSD-016

• Registration Number: NCT00740649
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-21
• Study First Submitted QC: 2008-08-22
• Study First Posted: 2008-08-25
• Study Start: 2008-10
• Status Verified: 2009-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Last Update Submitted: 2009-03-30
• Last Update Posted: 2009-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	placebo	placebo
1	HSD-016	HSD-016

Primary Outcome Measures

Name	Time	Method
clinical labs, adverse events	6 months