Study to Assess the Bioavailability of Different Formulations of AZD9977 and Dapagliflozin and Influence of Food in Selected Formulations in Healthy Volunteers
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to evaluate relative bioavailability of AZD9977 and
      dapagliflozin and compare the plasma concentration time profiles after dosing with different
      capsule formulations containing both AZD9977 and dapagliflozin or solely dapagliflozin, the
      AZD9977 capsule, and dapagliflozin tablet under fasted conditions.
    

Detailed description: 
      The study will be conducted at 2 study centers in Germany.

      Eligible participants will be randomized to one of the 8 treatment sequences (4 unique
      sequences to Group 1 and 4 unique sequences to Group 2). In Group 1, participants will
      receive 5 single dose treatments, while in Group 2 participants will receive 4 single dose
      treatments.

      Below treatments A, B, C, D and E will be given to participants in Group 1 and treatments A,
      F, G and H will be given to participants in Group 2 in randomized order:

        1. Treatment A: AZD9977 Dose A + 10 mg dapagliflozin tablet, fasted

        2. Treatment B: AZD9977 Dose A + 10 mg dapagliflozin capsule 1, fasted

        3. Treatment C: AZD9977 Dose A + 10 mg dapagliflozin capsule 1, fed

        4. Treatment D: AZD9977 Dose A + 10 mg dapagliflozin capsule 2, fasted

        5. Treatment E: AZD9977 Dose A + 10 mg dapagliflozin capsule 2, fed

        6. Treatment F: AZD9977 Dose A + 10 mg dapagliflozin capsule 3, fasted

        7. Treatment G: AZD9977 Dose A + 10 mg dapagliflozin capsule 4, fasted

        8. Treatment H: 10 mg dapagliflozin capsule, fasted

      The study will comprise of the following:

        -  A screening period of maximum 21 days.

        -  Four or five treatment periods during which participants will be resident at the study
           center from the day before dosing until at least 72 hours after the final dose.

        -  A final visit within 5 to 7 days after administration of the last treatment.

      Each participant will receive single dose treatments under fasted or fed conditions,
      separated by at least 4 days washout.

      Each participant will be involved in the study for approximately 6 to 7 weeks.
    

Intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D; Treatment E; Treatment F; Treatment G; Treatment H
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition.; Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition.; Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition; Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition.; Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition.; Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition.; Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition.; Participants will receive oral dose of dapagliflozin capsule in fasted condition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability; Oral selective mineralocorticoid receptor modulator; Pharmacokinetics; Dapagliflozin; AZD9977