Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AZD3366 in Healthy Subjects, Japanese and Chinese Subjects
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

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).
    

Detailed 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.
    

Intervention name(s): AZD3366; Placebo; Ticagrelor; acetylsalicylic acid (ASA)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): In Part A, subjects will be randomized to receive intravenous infusion AZD3366 dose 1-7, single ascending dose (SAD). In Part A, Dose 2-7 may be adjusted based on PK data from previous cohort[s]. In Part B, subjects will be randomized to receive intravenous infusion AZD3366 dose X (a dose resulting in predicted therapeutic exposure).; In Part A and Part B, subjects will be randomized to receive intravenous infusion of placebo (0.9% sodium chloride solution).; In Part B, subjects will receive oral ticagrelor tablets.; In Part B, subjects will receive oral ASA chewable tablets.
Other intervention name(s): Brilinta; Chewable aspirin
Intervention MeSH terms: Aspirin; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Cardiovascular disease; Acute myocardial infarction; Acute ischemic stroke; First in Human; Healthy subjects; Healthy Japanese subjects; Healthy Chinese subjects