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

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ClinicalTrials.gov Identifier: NCT00550381
Recruitment Status : Completed
First Posted : October 29, 2007
Last Update Posted : July 10, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: HKI-357 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ascending Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of HKI-357 Administered Orally to Healthy Subjects
Study Start Date : January 2008
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Safety, tolerability, PK [ Time Frame: 5 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Eligibility Criteria:

  • Healthy adult men or women of nonchildbearing potential, aged 18-50.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00550381     History of Changes
Other Study ID Numbers: 3235A1-1000
First Posted: October 29, 2007    Key Record Dates
Last Update Posted: July 10, 2009
Last Verified: July 2009

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