Study Evaluating HKI-272 Administered to Healthy Subjects
Sponsor
Puma Biotechnology, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00366600
Collaborator
(none)
56
1
5
11.1
Study Details
Study Description
Brief Summary
Safety and tolerability of HKI-272 in healthy subjects; the influence of food intake on the same.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
56 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HKI-272 Administered Orally to Healthy Subjects.
Study Start Date
:
Jul 1, 2006
Actual Primary Completion Date
:
Dec 1, 2006
Actual Study Completion Date
:
Dec 1, 2006
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics; safety and tolerability; influence of food on the same. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Healthy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwest Kinetics | Tacoma | Washington | United States | 98418 |
Sponsors and Collaborators
- Puma Biotechnology, Inc.
Investigators
- Study Director: Puma, Biotechnology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00366600
Other Study ID Numbers:
- 3144A1-107
First Posted:
Aug 21, 2006
Last Update Posted:
Sep 11, 2017
Last Verified:
Sep 1, 2017
Keywords provided by Puma Biotechnology, Inc.