A Randomized, Open Label Study to Compare the Current Phase II and Planned Phase III Capsule Formulation of AZD6244 - AZD6244Formula
Study identifier:D1532C00066
ClinicalTrials.gov identifier:NCT01635023
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Single-center, Randomized, Open-label, Crossover Study to Compare the White (Current Phase II) and Blue (Planned Phase III) Capsule Formulations of AZD6244 Hyd-Sulfate in Healthy Male Subjects
Medical condition
Healthy Volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD6244 Dosing Period 1, AZD6244 Dosing Period 1, AZD6244 Dosing Period 1, AZD6244 Dosing Period 2, AZD6244 Dosing Period 2, AZD6244 Dosing Period 2, AZD6244 Dosing Period 3, AZD6244 Dosing Period 3, AZD6244 Dosing Period 3, AZD6244 Dosing Period 4
Sex
Male
Actual enrollment
109
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 02 Jul 2012
Primary Completion Date: 18 Oct 2012
Study Completion Date: 18 Oct 2012
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Oct 2017 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD6244 white capsule 75mg AZD6244 white (current Phase II) capsule | Drug: AZD6244 Dosing Period 1 Treatment A, B, or C depending on randomization assignment Other Name: AZD6244 Drug: AZD6244 Dosing Period 2 Treatment A, B, or C depending on randomization assignment Other Name: AZD6244 Drug: AZD6244 Dosing Period 3 Treatment A, B, or C depending on randomization assignment Other Name: AZD6244 |
| Experimental: AZD6244 blue capsule 75mg AZD6244 blue (planned Phase III) capsule | Drug: AZD6244 Dosing Period 1 Treatment A, B, or C depending on randomization assignment Other Name: AZD6244 Drug: AZD6244 Dosing Period 2 Treatment A, B, or C depending on randomization assignment Other Name: AZD6244 Drug: AZD6244 Dosing Period 3 Treatment A, B, or C depending on randomization assignment Other Name: AZD6244 Drug: AZD6244 Dosing Period 4 Treatment B Other Name: AZD6244 |
| Experimental: AZD6244 solution 35mg AZD6244 oral solution | Drug: AZD6244 Dosing Period 1 Treatment A, B, or C depending on randomization assignment Other Name: AZD6244 Drug: AZD6244 Dosing Period 2 Treatment A, B, or C depending on randomization assignment Other Name: AZD6244 Drug: AZD6244 Dosing Period 3 Treatment A, B, or C depending on randomization assignment Other Name: AZD6244 |
Contacts
Investigators
Principal Investigator
Ian Smith
AstraZeneca
