Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AZD3366 in Healthy Subjects, Japanese and Chinese Subjects

Study identifier:D2911C00001

ClinicalTrials.gov identifier:NCT04588727

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3366 in Healthy Men and Women of Non-Childbearing Potential Following: Part A: Single Ascending Dose Administration (Including Populations of Japanese and Chinese Subjects) Part B: Single Dose Administration of AZD3366 at One Dose Level or Placebo with Concomitant Repeated Dosing of Ticagrelor and Acetylsalicylic Acid

Medical condition

cardiovascular disease

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD3366, AZD3366, AZD3366, AZD3366, AZD3366, AZD3366, AZD3366, AZD3366, Placebo, Placebo, Ticagrelor, Ticagrelor, acetylsalicylic acid (ASA), acetylsalicylic acid (ASA)

Sex

All

Actual enrollment

103

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 15 Oct 2020
Primary Completion Date: 10 Jan 2022
Study Completion Date: 10 Jan 2022

Study design

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

Verification:

Verified 01 May 2022 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria