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

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.

Conditions

• Heart Failure

Interventions

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.

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.

Sponsors & Collaborators

• Parexel

  collaborator INDUSTRY

• AstraZeneca

  lead INDUSTRY

Principal Investigators

• Ozan Dursun · Parexel Early Phase Clinical Unit Berlin Campus DRK Kliniken Berlin Westend, Haus 31 Spandauer Damm 130 14050 Berlin Germany

• Alen Jambrecina · CTC North GmbH & Co. KG Martinistrasse 64 20251 Hamburg Germany

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-06-29

Primary Completion

2021-09-03

Completion

2021-09-03

Countries

• Germany

Study Locations