Study to Assess the Bioavailability of Different Formulations of AZD9977 and Dapagliflozin and Influence of Food in Selected Formulations in Healthy Volunteers

Heart Failure Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT04798222
• Study type: Interventional
• Source: AstraZeneca
• Status: Completed
• Phase: Phase 1
• Start date: June 29, 2021
• Completion date: September 3, 2021