Study Evaluating HTC-867 in Healthy Young and Elderly Subjects

Phase 1

Terminated

• Conditions: Healthy Subjects
• Interventions: Drug: HTC-867; Other: Placebo

• Registration Number: NCT00827489
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to assess the safety and tolerability of ascending single oral doses of HTC-867 in healthy young and elderly subjects. This study will also evaluate the way the drug enters and leaves the blood and tissues over time and how the drug acts on and in the body in a fasted and fed state.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-01
• Last Update Posted: 2009-09-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HTC-867	HTC-867	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety as measured by the number of adverse events and serious adverse events. Tolerability as measured by occurrence of dose limiting toxicities.	5 months

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic and pharmacodynamic parameters.	5 months