Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability

PHASE1CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

February 28, 2015

Study Completion Date

July 31, 2015

Conditions
Advanced Solid Malignancy,Safety and Tolerability,Pharmacokinetics, Pharmacodynamics,Tumour Response,
Interventions
DRUG

AZD5363

Oral AZD5363 twice daily, 4 days on 3 days off: tablet formulation for one week, followed by two weeks with capsule formulation.

DRUG

AZD5363

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.

Trial Locations (3)

1066 CX

Research Site, Amsterdam

M20 4BX

Research Site, Manchester

SM2 5PT

Research Site, Surrey

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY