Study to assess the effect of rifampicin (CYP inducer) on blood levels and safety of olaparib in patients with advanced solid tumours

Study identifier:D0816C00008

ClinicalTrials.gov identifier:NCT01929603

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Non-randomised, Open-label, Sequential, Multicentre, Two-part, Phase I Study to Assess the Effect of Rifampicin, a CYP Inducer, on the Pharmacokinetics of Olaparib Following Oral Dosing of a Tablet Formulation in Patients with Advanced Solid Tumours

Medical condition

Solid tumours

Phase

Phase 1

Healthy volunteers

No

Study drug

Rifampicin, Olaparib tablet dosing

Sex

All

Actual Enrollment

32

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 01 Dec 2013
Primary Completion Date: 01 May 2014
Study Completion Date: 01 Nov 2016

Study design

Allocation: N/A
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Jan 2017 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria