Trials / Completed
CompletedNCT01929603
Study to Assess the Effect of Rifampicin (CYP Inducer) on Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the effect of rifampicin on the PK parameters of olaparib in patients; Part B will allow patients continued access to olaparib after the PK phase and will provide additional safety data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Pharmacokinetic sampling | Blood sampling to measure olaparib, rifampicin and 4β-hydroxycholesterol |
| DRUG | Rifampicin | Rifampicin (CYP inducer) 600mg taken once daily from Day 5 to Day 14 (Part A) |
| DRUG | Olaparib tablet dosing | Olaparib 300mg tablet taken on Days 1 and 14 (Part A). Part B dosing is 300mg olaparib bi-daily |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2014-05-01
- Completion
- 2016-11-01
- First posted
- 2013-08-28
- Last updated
- 2017-01-16
Locations
5 sites across 2 countries: Belgium, Netherlands
Source: ClinicalTrials.gov record NCT01929603. Inclusion in this directory is not an endorsement.