Study identifier:D6402C00003
ClinicalTrials.gov identifier:NCT04798222
EudraCT identifier:2021-000483-30
CTIS identifier:N/A
An Open-label, Randomized, Parallel Group, Four/Five Period, Eight Treatment Cross-over, Single Oral Dose Study to Assess the Relative Bioavailability of Different Formulations of AZD9977 and Dapagliflozin and Influence of Food in Selected Formulations in Healthy Volunteers
heart failure
Phase 1
Yes
Treatment A, Treatment B, Treatment C, Treatment D, Treatment E, Treatment F, Treatment G, Treatment H
All
20
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Basic Science
Verified 01 Jun 2023 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Group 1: Treatment Sequence ABECD Participants will receive a single oral dose of Treatments A, B, E, C, and D in Treatment periods 1 to 5 on Day 1 of the study. | Drug: Treatment A Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. Drug: Treatment B Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition. Drug: Treatment C Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition Drug: Treatment D Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition. Drug: Treatment E Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition. |
Experimental: Group 1: Treatment Sequence BACED Participants will receive a single oral dose of Treatments B, A, C, E, and D in Treatment periods 1 to 5 on Day 1 of the study. | Drug: Treatment A Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. Drug: Treatment B Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition. Drug: Treatment C Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition Drug: Treatment D Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition. Drug: Treatment E Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition. |
Experimental: Group 1: Treatment Sequence CDBEA Participants will receive a single oral dose of Treatments C, D, B, E, and A in Treatment periods 1 to 5 on Day 1 of the study. | Drug: Treatment A Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. Drug: Treatment B Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition. Drug: Treatment C Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition Drug: Treatment D Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition. Drug: Treatment E Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition. |
Experimental: Group 1: Treatment Sequence EADBC Participants will receive a single oral dose of Treatments E, A, D, B, and C in Treatment periods 1 to 5 on Day 1 of the study. | Drug: Treatment A Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. Drug: Treatment B Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition. Drug: Treatment C Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition Drug: Treatment D Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition. Drug: Treatment E Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition. |
Experimental: Group 2: Treatment Sequence AFHG Participants will receive a single oral dose of Treatments A, F, H, and G in Treatment periods 1 to 4 on Day 1 of the study. | Drug: Treatment A Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. Drug: Treatment F Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition. Drug: Treatment G Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition. Drug: Treatment H Participants will receive oral dose of dapagliflozin capsule in fasted condition. |
Experimental: Group 2: Treatment Sequence FGAH Participants will receive a single oral dose of Treatments F, G, A, and H in Treatment periods 1 to 4 on Day 1 of the study. | Drug: Treatment A Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. Drug: Treatment F Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition. Drug: Treatment G Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition. Drug: Treatment H Participants will receive oral dose of dapagliflozin capsule in fasted condition. |
Experimental: Group 2: Treatment Sequence GHFA Participants will receive a single oral dose of Treatments G, H, F, and A in Treatment periods 1 to 4 on Day 1 of the study. | Drug: Treatment A Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. Drug: Treatment F Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition. Drug: Treatment G Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition. Drug: Treatment H Participants will receive oral dose of dapagliflozin capsule in fasted condition. |
Experimental: Group 2: Treatment Sequence HAGF Participants will receive a single oral dose of Treatments H, A, G, and F in Treatment periods 1 to 4 on Day 1 of the study. | Drug: Treatment A Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. Drug: Treatment F Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition. Drug: Treatment G Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition. Drug: Treatment H Participants will receive oral dose of dapagliflozin capsule in fasted condition. |