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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00550381
First received: October 26, 2007
Last updated: July 8, 2009
Last verified: July 2009
  Purpose

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


Condition Intervention Phase
Healthy
Drug: HKI-357
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Ascending Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of HKI-357 Administered Orally to Healthy Subjects

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Safety, tolerability, PK [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 72
Study Start Date: January 2008
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
10mg
Drug: HKI-357
Single-dose capsule
Placebo Comparator: 2
20mg
Drug: HKI-357
Single-dose capsule
Placebo Comparator: 3
40mg
Drug: HKI-357
Single-dose capsule
Placebo Comparator: 4
80mg
Drug: HKI-357
Single-dose capsule
Placebo Comparator: 5
160mg
Drug: HKI-357
Single-dose capsule
Placebo Comparator: 6
240mg
Drug: HKI-357
Single-dose capsule
Placebo Comparator: 7
400mg
Drug: HKI-357
Single-dose capsule
Placebo Comparator: 8
640mg
Drug: HKI-357
Single-dose capsule
Placebo Comparator: 9
960mg
Drug: HKI-357
Single-dose capsule
Placebo Comparator: 10
placebo
Drug: HKI-357
Single-dose capsule

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Eligibility Criteria:

  • Healthy adult men or women of nonchildbearing potential, aged 18-50.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550381

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
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00550381     History of Changes
Other Study ID Numbers: 3235A1-1000
Study First Received: October 26, 2007
Last Updated: July 8, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
healthy subjects

ClinicalTrials.gov processed this record on April 14, 2014