A single oral dose study to evaluate four different formulations of AZD9977 and the effect of food in healthy male subjects

Study identifier:D6401C00002

ClinicalTrials.gov identifier:NCT03450759

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open-label, Randomized, Four-way Cross-over, Single Oral Dose Study Comparing the Pharmacokinetics of Four Different Formulations of AZD9977 (Part A) and Influence of Food (Part B) in Healthy Male Subjects

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD9977 Oral suspension (reference), AZD9977 capsule, AZD9977 ER capsule (fastvrate), AZD9977 ER capsule (Int. rate)

Sex

Male

Actual Enrollment

13

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 28 Mar 2018
Primary Completion Date: 06 Jun 2018
Study Completion Date: 06 Jun 2018

Study design

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

Verification:

Verified 01 Feb 2019 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria