Trials / Completed
CompletedNCT00849329
A Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects With Metastatic ErbB2 Positive Breast Cancer
An Open-Label, Two-Part, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects With Metastatic ErbB2
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study will characterize the effect of elevated gastric pH mediated by the proton-pump inhibitor, esomeprazole, on the relative bioavailability of lapatinib in subjects with metastatic ErbB2 positive breast cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lapatinib | 1250mg lapatinib |
| DRUG | lapatinib plus esomeprazole | 1250mg lapatinib plus esomeprazole 40mg |
Timeline
- Start date
- 2009-03-10
- Primary completion
- 2009-11-24
- Completion
- 2009-11-24
- First posted
- 2009-02-23
- Last updated
- 2017-11-14
Locations
4 sites across 3 countries: United States, South Korea, Spain
Source: ClinicalTrials.gov record NCT00849329. Inclusion in this directory is not an endorsement.