A Study to Assess the Amount of Drug Levels in Blood and Safety of AZD5718 Formulations in Healthy Volunteers
Condition: Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a randomized, single-dose, open-label, combined 2x2 dose and 3x3 dose crossover
      design in fixed sequence. In this study, the relative bioavailability of different
      formulations of AZD5718 will be assessed in healthy volunteers in order to compare the
      exposure of Formulations A to D to the AZD5718 film-coated tablet formulation. The overall
      treatment period will start with a 2-period, 2-dose treatment crossover, followed by a
      3-period, 3-dose treatment crossover.
    

Detailed description: 
      This study will be conducted at a single study center in Parexel Early Phase Clinical Unit
      London.

      A total of 12 healthy male and female volunteers (of non-childbearing potential) will be
      randomized.

      The study will comprise:

        -  A screening period of maximum 28 days

        -  Five treatment periods

        -  There will be a washout period of 3 to 6 days between dose administrations

        -  Follow-up visit, 5 to 7 days after last dose

      Each volunteer will be involved in the study for between 7 and 9 weeks. The volunteers will
      be admitted to the Unit on the day before first dosing in Treatment Period 1 until at least
      72 hours after last dosing in Treatment Period 5.
    

Intervention name(s): AZD5718 tablet, Formulation A; AZD5718 tablet, Formulation B; AZD5718 tablet, Formulation C; AZD5718 tablet, Formulation D; AZD5718 film-coated tablet, Reference treatment
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Volunteers will receive single doses of AZD5718 tablet, Formulation A under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.; Volunteers will receive single doses of AZD5718 tablet, Formulation B under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.; Volunteers will receive single doses of AZD5718 tablet, Formulation C under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.; Volunteers will receive single doses of AZD5718 tablet, Formulation D under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.; Volunteers will receive single doses of AZD5718 film-coated tablet, Reference treatment under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The overall treatment period will start with a 2-period, 2-dose treatment crossover, followed by a 3-period, 3-dose treatment crossover.
The following treatments will be given:
Treatment A: AZD5718 (Formulation A) Treatment B: AZD5718 (Formulation B) Treatment C: AZD5718 (Formulation C) Treatment D: AZD5718 (Formulation D) AZD5718 (AZD5718 film-coated tablet, Reference treatment)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relative Bioavailability; Crossover Study; Safety