Trials / Withdrawn
WithdrawnNCT00932464
Study Evaluating The Effect Of A High-Fat Meal On The Pharmacokinetics Of Neratinib
An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study To Determine The Effect Of A High-Fat Meal On The Relative Bioavailability And Pharmacokinetics Of A Single Dose Of The 240 mg Formulation Of Neratinib In Healthy Subjects
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Puma Biotechnology, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
This study is being conducted to see if neratinib is absorbed, distributed, or eliminated differently when administered in the fasting state versus after a high-fat meal.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Neratinib | 240-mg oral tablet; single dose under fasted conditions |
| DRUG | Neratinib | 240-mg oral tablet; single dose with high-fat breakfast |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2012-08-01
- Completion
- 2012-08-01
- First posted
- 2009-07-03
- Last updated
- 2012-05-14
Source: ClinicalTrials.gov record NCT00932464. Inclusion in this directory is not an endorsement.