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 2, 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
