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

Sponsor
AstraZeneca
Study ID
NCT01921140
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumours

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 24, 2013
Status verified
Nov 2022
Primary completion
Apr 8, 2014
Completion
Mar 15, 2022

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Fasted
    Olaparib tablets following no breakfast
  • Other: High-fat meal
    Olaparib tablets after high-fat breakfast

Primary Outcome Measure

Pharmacokinetics of olaparib: area under the plasma-time curve from zero to infinity (AUC) [ Time Frame: Blood samples will be collected in both treatment periods of Part A: pre-dose, 0.25, 0.5, 1, 1.5 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post olaparib dose. In Part B Day -1 and Day 5: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, & 12 hours post dose. ]

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