A Phase I, Open-Label, Multicentre Study to Compare Two Dosage Formulations of AZD5363 and to Establish the Effect of Food on the Pharmacokinetic Exposure, Safety and Tolerability of AZD5363 in Patients with Advanced Solid Malignancies
Advanced solid malignancy,
18 Years - 100 Years
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Apr 2016 by AstraZeneca
No locations available
|Experimental: Part A: Formulation Switch|
AZD5363 tablet twice daily followed by AZD5363 capsule twice daily on an intermittent regimen (4 days on, 3 days off).
Oral AZD5363 twice daily, 4 days on 3 days off: tablet formulation for one week, followed by two weeks with capsule formulation.
|Experimental: Part B: Food effect|
AZD5363 tablet twice daily on an intermittent regimen (4 days on, 3 days off) with/without food on one occasion
Oral AZD5363 twice daily, 4 days on 3 days off, tablet formulation. On day 4 AZD5363 tablet without food. On day 11 AZD5363 tablet with food.