Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016

Phase 1

Completed

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

• Registration Number: NCT00739232
• 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 its effect on the body.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-20
• Study First Submitted QC: 2008-08-20
• Study First Posted: 2008-08-21
• Study Start: 2008-09
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-31
• Last Update Posted: 2009-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• 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
Active	HSD-016	Active
Placebo	placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	3 months

Secondary Outcome Measures

Name	Time	Method
Profiles of Drug Concentrations	3 months