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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
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
Research Site
Berlin, Germany
Area under plasma concentration time curve from zero to infinity (AUCinf)
Evaluation of AUCinf of AZD9977 and dapagliflozin, after dosing with different capsule formulations containing both AZD9977 and dapagliflozin or solely dapagliflozin, the AZD9977 capsule, and dapagliflozin tablet under fasted conditions.
Time frame: Day 1 until Day 4 of each Treatment Period (Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Area under the plasma concentration time curve from zero to the last quantifiable concentration (AUClast)
Evaluation of AUClast of AZD9977 and dapagliflozin, after dosing with different capsule formulations containing both AZD9977 and dapagliflozin or solely dapagliflozin, the AZD9977 capsule, and dapagliflozin tablet under fasted conditions.
Time frame: Day 1 until Day 4 of each Treatment Period (Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Maximum observed plasma (peak) drug concentration (Cmax)
Evaluation of Cmax of AZD9977 and dapagliflozin, after dosing with different capsule formulations containing both AZD9977 and dapagliflozin or solely dapagliflozin, the AZD9977 capsule, and dapagliflozin tablet under fasted conditions.
Time frame: Day 1 until Day 4 of each Treatment Period (Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Drug concentration in plasma at 24 hours post-dose (C24)
Evaluation of C24 of AZD9977 and dapagliflozin, after dosing with different capsule formulations containing both AZD9977 and dapagliflozin or solely dapagliflozin, the AZD9977 capsule, and dapagliflozin tablet under fasted conditions.
Time frame: Day 1 until Day 4 of each Treatment Period (Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
AUCinf of AZD9977 and dapagliflozin
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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.
Evaluation of AUCinf of AZD9977 and dapagliflozin after dosing with 2 different capsule formulations (AZD9977 + dapagliflozin) under fed and fasted conditions.
Time frame: Day 1 until Day 4 of each Treatment Period (Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
AUClast of AZD9977 and dapagliflozin
Evaluation of AUClast of AZD9977 and dapagliflozin after dosing with 2 different capsule formulations (AZD9977 + dapagliflozin) under fed and fasted conditions.
Time frame: Day 1 until Day 4 of each Treatment Period (Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Cmax of AZD9977 and dapagliflozin
Evaluation of Cmax of AZD9977 and dapagliflozin after dosing with 2 different capsule formulations (AZD9977 + dapagliflozin) under fed and fasted conditions.
Time frame: Day 1 until Day 4 of each Treatment Period (Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
C24 of AZD9977 and dapagliflozin
Evaluation of C24 of AZD9977 and dapagliflozin after dosing with 2 different capsule formulations (AZD9977 + dapagliflozin) under fed and fasted conditions.
Time frame: Day 1 until Day 4 of each Treatment Period (Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
AUCinf of AZD9977
Evaluation of AUCinf of AZD9977 in different capsules against each other under fasted conditions.
Time frame: Day 1 until Day 4 of each Treatment Period (Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
AUClast of AZD9977
Evaluation of AUClast of AZD9977 in different capsules against each other under fasted conditions.
Time frame: Day 1 until Day 4 of each Treatment Period (Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Cmax of AZD9977
Evaluation of Cmax of AZD9977 in different capsules against each other under fasted conditions.
Time frame: Day 1 until Day 4 of each Treatment Period (Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
C24 of AZD9977
Evaluation of C24 of AZD9977 in different capsules against each other under fasted conditions.
Time frame: Day 1 until Day 4 of each Treatment Period (Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
AUCinf of dapagliflozin
Evaluation of AUCinf of dapagliflozin in different capsules against each other under fasted conditions.
Time frame: Day 1 until Day 4 of each Treatment Period (Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
AUClast of dapagliflozin
Evaluation of AUClast of dapagliflozin in different capsules against each other under fasted conditions.
Time frame: Day 1 until Day 4 of each Treatment Period (Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Cmax of dapagliflozin
Evaluation of Cmax of dapagliflozin in different capsules against each other under fasted conditions.
Time frame: Day 1 until Day 4 of each Treatment Period (Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
C24 of dapagliflozin
Evaluation of C24 of dapagliflozin in different capsules against each other under fasted conditions.
Time frame: Day 1 until Day 4 of each Treatment Period (Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Number of participants with adverse events
Assessment of the safety and tolerability of single doses of AZD9977 and dapagliflozin in healthy participants.
Time frame: From screening until follow-up visit (5 to 7 days post final dose)