NCT01921140

To Determine the Effect of Food on the Pharmacokinetics of Olaparib and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation in Patients With Advanced Solid Tumours

A Randomised, Open-label, Three-part, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of Olaparib and to Provide Data on the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation in Patients With Advanced Solid Tumours

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a 3 part study for patients with solid tumours. The purpose of Part A is to measure the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after eating and the effect of olaparib on QT interval following a single oral dose of olaparib tablets. Part B will determine the effect of olaparib on the QT interval following multiple oral dosing. Part C will allow patients continued access to olaparib tablets and will provide additional safety data collection.

Conditions

• Solid Tumours

Interventions

Type	Name	Description
DRUG	Olaparib tablets	Olaparib dosing (2X 150mg tablets) following allocated meal
PROCEDURE	Pharmacokinetic sampling	Blood samples taken pre and post dosing with 2x 150 mg olaparib tablet
OTHER	Dietary Fasted	2x 150 mg olaparib tablet formulation taken in fasted state. 5-14 days washout period
OTHER	Dietary High Fat	2x 150 mg olaparib tablet formulation taken 30 minutes after allocated meal. 5-14 days washout period.

Timeline

• Start date: 2013-09-24
• Primary completion: 2014-04-08
• Completion: 2022-03-15
• First posted: 2013-08-13
• Last updated: 2022-11-22

Locations

12 sites across 4 countries: Belgium, Denmark, Netherlands, United Kingdom