A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male participants

Study identifier:D1532C00089

ClinicalTrials.gov identifier:NCT03649165

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open-label, Single-center Relative Bioavailability and Food Effect Randomized Crossover Study of New Granule and Capsule Formulations of Selumetinib (AZD6244) in Healthy Male Subjects

Medical condition

Neurofibromatosis type 1 (NF1)-related plexiform neurofibromas (PNs), Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Treatment A, Treatment A, Treatment A, Treatment A, Treatment B, Treatment B, Treatment B, Treatment B, Treatment C, Treatment C, Treatment C, Treatment C, Treatment D, Treatment D, Treatment D, Treatment D, Acetaminophen, Acetaminophen, Acetaminophen, Acetaminophen

Sex

Male

Actual enrollment

24

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 05 Sept 2018
Primary Completion Date: 21 Oct 2018
Study Completion Date: 21 Oct 2018

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2019 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria