Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy Subjects
- Registration Number
- NCT00550381
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 HKI-357 10mg 10 HKI-357 placebo 5 HKI-357 160mg 6 HKI-357 240mg 3 HKI-357 40mg 4 HKI-357 80mg 2 HKI-357 20mg 7 HKI-357 400mg 8 HKI-357 640mg 9 HKI-357 960mg
- Primary Outcome Measures
Name Time Method Safety, tolerability, PK 5 days
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular targets of HKI-357 in phase 1 clinical trials for healthy subjects?
How does the pharmacokinetics of HKI-357 compare to other tyrosine kinase inhibitors in early-phase studies?
What adverse events are associated with HKI-357 administration in healthy volunteers and how are they managed?
Are there any biomarkers identified for predicting tolerability of HKI-357 in phase 1 trials?
What is the therapeutic potential of HKI-357 in diseases beyond its initial safety evaluation in healthy subjects?