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

Cardiovascular Disease Clinical Trial

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

Status Completed

Clinical Trial Summary

Part A of this study is a Phase 1, First-in-human (FiH), randomized, single-blind, placebo controlled study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD3366 following single intravenous (IV) ascending doses. Part B of this study is a randomized, single-blind, parallel group placebo-controlled study to assess the safety, tolerability and PD of a single IV administration of AZD3366 with concomitant loading doses followed by repeated maintenance dosing of ticagrelor and acetylsalicylic acid (ASA).

Clinical Trial Description

The study will provide data on safety, tolerability, PK, and PD of AZD3366 in healthy subjects. Three populations (healthy subjects, healthy Japanese subjects and healthy Chinese subjects) will be enrolled into this study. This study will be conducted at a single study center in United States of America (USA). Part A of the study will investigate the safety, tolerability, PK, and PD (inhibition of platelet aggregation and capillary bleeding time [CBT]) of an IV administration of single ascending doses (SAD) of AZD3366 in healthy subjects, healthy Japanese subjects and healthy Chinese subjects. Part B of the study will investigate the safety, tolerability, and PD (inhibition of platelet aggregation and CBT) of a single IV dose of AZD3366 or placebo with concomitant administration of ticagrelor and ASA by a parallel group cohort consisting of of healthy subjects. Furthermore, the potential effect of AZD3366 on the PK of ticagrelor will be investigated. Co-medication with ASA and ticagrelor is chosen based on the Standard of Care anti-platelet treatment regimen in patients with myocardial infarction. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04588727
Study type	Interventional
Source	AstraZeneca
Contact
Status	Completed
Phase	Phase 1
Start date	October 15, 2020
Completion date	January 19, 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.