A Non-randomised, Open-label, Sequential, Three-part, Phase I Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of Olaparib Following Oral Dosing of a Tablet Formulation, and to Provide Data on the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation to Patients with Advanced Solid Tumours
Olaparib tablet dosing, Itraconazole
18 Years - 130 Years
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Other
Verified 01 Oct 2016 by AstraZeneca
No locations available
|Experimental: Olaparib alone, olaparib+itraconozole|
Sequential treatments of olaparib alone followed by olaparib+itraconazole, with a washout period in between.
Procedure/Surgery: Pharmacokinetic sampling
Blood samples taken pre and post dosing with olaparib+/- itraconazole
Drug: Olaparib tablet dosing
Olaparib tablets: Part A 100mg od, days 1 and 9 only. Part B 10x300mg doses over 5 days (300mg bd).
Itraconazole 200mg od Part A days 5 to 11 only