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