Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability - OAK
Study identifier:D3610C00007
ClinicalTrials.gov identifier:NCT01895946
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Advanced solid malignancy,
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD5363
Sex
All
Actual Enrollment
33
Study type
Interventional
Age
18 Years - 100 Years
Date
Study Start Date: 01 Dec 2013
Primary Completion Date: 01 Feb 2015
Study Completion Date: 01 Jul 2015
Study design
Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| 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). | Drug: AZD5363 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 | 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. |
Contacts
Investigators
Principal Investigator
Justin Lindemann
AstraZeneca
