D081AC00001 Food interaction with olaparib capsule in patients with solid tumours
Study identifier:D081AC00001
ClinicalTrials.gov identifier:NCT01851265
EudraCT identifier:2013-001255-13
CTIS identifier:N/A
Study Complete
Official Title
A Two-part, Randomised, Open-label, Multicentre, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of Olaparib Following Single 400 mg Doses of the Capsule Formulation in Patients with Advanced Solid Tumours.
Medical condition
Solid tumours
Phase
Phase 1
Healthy volunteers
No
Study drug
Olaparib
Sex
All
Actual Enrollment
32
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 04 Jul 2013
Primary Completion Date: 18 Oct 2013
Study Completion Date: 06 Jun 2017
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other
Verification:
Verified 01 Aug 2017 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Other: Fasted Olaparib capsules following no breakfast | Drug: Olaparib 400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms. Other: Dietary Fasted Allocated breakfast prior to dosing with 400mg olaparib capsules |
| Other: Standard meal Olaparib capsules after standard breakfast | Drug: Olaparib 400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms. Other: Dietary standard Allocated breakfast prior to dosing with 400mg olaparib capsules |
| Other: High Fat Olaparib capsules after high fat breakfast | Drug: Olaparib 400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms. Other: Dietary High Fat Allocated breakfast prior to dosing with 400mg olaparib capsules |
Contacts
Investigators
Principal Investigator
Anitra Fielding
AstraZeneca Senior Research Physician
