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

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 24, 2013

Primary Completion Date

April 8, 2014

Study Completion Date

March 15, 2022

Conditions
Solid Tumours
Interventions
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.

Trial Locations (12)

1090

Research Site, Brussels

2100

Research Site, København Ø

2730

Research Site, Herlev

3000

Research Site, Leuven

4000

Research Site, Liège

6202 AZ

Research Site, Maastricht

6525 GA

Research Site, Nijmegen

3584 CX

Research Site, Utrecht

SE1 9RT

Research Site, London

M20 4BX

Research Site, Manchester

NE7 7DN

Research Site, Newcastle upon Tyne

SM1 2DL

Research Site, Surrey

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY