NCT00258050

To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients

A Four-Way Cross-Over Study to Examine the Effects of Lapatinib on the Pharmacokinetics of Orally and Intravenously Administered Midazolam in Cancer Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To characterize the effect of repeat oral dose of lapatinib treatment on the pharmacokinetics of a single oral and single intravenous dose of midazolam in adult cancer patients. Also to assess the safety and tolerability of chronic oral lapatinib therapy in cancer patients.

Conditions

• Neoplasms, Breast

Interventions

Type	Name	Description
DRUG	Midazolam	Subjects will receive midazolam by oral or IV route on Days 1, 3, 9 and 11. Oral midazolam was supplied as 3 mg tablets; IV midazolam was supplied as 1 milligram per milliliter (mg/L) sterile solution.
DRUG	Lapatinib	Subjects will receive 1500 mg lapatinib by oral route once daily from Day 4.

Timeline

• Start date: 2005-11-21
• Primary completion: 2007-02-08
• Completion: 2007-02-08
• First posted: 2005-11-24
• Last updated: 2017-12-06

Locations

2 sites across 1 country: United States