Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HKI-357

• Registration Number: NCT00550381
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single doses of HKI-357 administered to healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-26
• Study First Submitted QC: 2007-10-26
• Study First Posted: 2007-10-29
• Study Start: 2008-01
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-08
• Last Update Posted: 2009-07-10

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	HKI-357	10mg
10	HKI-357	placebo
5	HKI-357	160mg
6	HKI-357	240mg
3	HKI-357	40mg
4	HKI-357	80mg
2	HKI-357	20mg
7	HKI-357	400mg
8	HKI-357	640mg
9	HKI-357	960mg

Primary Outcome Measures

Name	Time	Method
Safety, tolerability, PK	5 days