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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

NCT01921140 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-11-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Olaparib tablets

Olaparib dosing (2X 150mg tablets) following allocated meal

PROCEDURE

Pharmacokinetic sampling

Blood samples taken pre and post dosing with 2x 150 mg olaparib tablet

OTHER

Dietary Fasted

2x 150 mg olaparib tablet formulation taken in fasted state. 5-14 days washout period

OTHER

Dietary High Fat

2x 150 mg olaparib tablet formulation taken 30 minutes after allocated meal. 5-14 days washout period.

Sponsors & Collaborators

Principal Investigators

  • Anitra Fielding · AstraZeneca Sponsor Research Physician

  • Ruth Plummer, Prof · Northern Centre for Cancer Care, Newcastle Upon Tyne Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-24
Primary Completion
2014-04-08
Completion
2022-03-15

Countries

  • Belgium
  • Denmark
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01921140 on ClinicalTrials.gov