Study identifier:D1532C00066
ClinicalTrials.gov identifier:NCT01635023
EudraCT identifier:N/A
CTIS identifier:N/A
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
Healthy Volunteers
Phase 1
Yes
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
Male
109
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Oct 2017 by AstraZeneca
AstraZeneca
-
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 |