D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours

Sponsor
AstraZeneca
Study ID
NCT01851265
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumours

Eligibility Criteria

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

Interventions

  • Olaparib — DRUG
    400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.
  • Dietary Fasted — OTHER
    Allocated breakfast prior to dosing with 400mg olaparib capsules
  • Dietary standard — OTHER
    Allocated breakfast prior to dosing with 400mg olaparib capsules
  • Dietary High Fat — OTHER
    Allocated breakfast prior to dosing with 400mg olaparib capsules

Study Details

This is a 2 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 3 different breakfasts (high calorie, regular and none). In Part B Patients can take olaparib capsules daily and study assessments will be recorded for 6 months (minimum). Treatment can continue for as long as the patient is benefitting. Throughout the study patients will be monitored for any side effects.

Key Dates

Start date
Jul 4, 2013
Status verified
Aug 2017
Primary completion
Oct 18, 2013
Completion
Jun 6, 2017

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Other: Fasted
    Olaparib capsules following no breakfast
  • Other: Standard meal
    Olaparib capsules after standard breakfast
  • Other: High Fat
    Olaparib capsules after high fat breakfast

Primary Outcome Measure

Pharmacokinetics of Olaparib (Cmax and tmax) [ Time Frame: Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose ]

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