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

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Overland Park, KS, United States

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

"There is no result for the study"

Documents available

D1532C00066_RevisedCSP1Redaction4
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

Quintiles Overland Park Volunteer Recruitment

913-894-5533

Investigators

Principal Investigator

Ian Smith

AstraZeneca