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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014