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

July 8, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

Ascending Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of HKI-357 Administered Orally to Healthy Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Eligibility Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety, tolerability, PK
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

October 26, 2007

First Submitted That Met QC Criteria

October 26, 2007

First Posted (Estimate)

October 29, 2007

Study Record Updates

Last Update Posted (Estimate)

July 10, 2009

Last Update Submitted That Met QC Criteria

July 8, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3235A1-1000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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