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 A, Treatment A, Treatment A, Treatment A, Treatment A, Treatment A, Treatment A, Treatment B, Treatment B, Treatment B, Treatment B, Treatment C, Treatment C, Treatment C, Treatment C, Treatment D, Treatment D, Treatment D, Treatment D, Treatment E, Treatment E, Treatment E, Treatment E, Treatment F, Treatment F, Treatment F, Treatment F, Treatment G, Treatment G, Treatment G, Treatment G, Treatment H, Treatment H, Treatment H, Treatment H
All
20
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Basic Science
Verified 01 Sept 2021 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. |