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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000483-30 | EudraCT Number |
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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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:
The study will comprise of the following:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Treatment Sequence ABECD | Experimental | 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. |
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| Group 1: Treatment Sequence BACED | Experimental | 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. |
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| Group 1: Treatment Sequence CDBEA | Experimental | 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. |
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| Group 1: Treatment Sequence EADBC | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A | Drug | Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of AZD9977 and dapagliflozin | Evaluation of AUCinf of AZD9977 and dapagliflozin after dosing with 2 different capsule formulations (AZD9977 + dapagliflozin) under fed and fasted conditions. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ozan Dursun | Parexel Early Phase Clinical Unit Berlin Campus DRK Kliniken Berlin Westend, Haus 31 Spandauer Damm 130 14050 Berlin Germany | Principal Investigator |
| Alen Jambrecina | CTC North GmbH & Co. KG Martinistrasse 64 20251 Hamburg Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | 14050 | Germany |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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| Group 2: Treatment Sequence AFHG |
| Experimental |
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. |
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| Group 2: Treatment Sequence FGAH | Experimental | 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. |
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| Group 2: Treatment Sequence GHFA | Experimental | 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. |
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| Group 2: Treatment Sequence HAGF | Experimental | 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. |
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| Treatment B | Drug | Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition. |
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| Treatment C | Drug | Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition |
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| Treatment D | Drug | Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition. |
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| Treatment E | Drug | Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition. |
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| Treatment F | Drug | Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition. |
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| Treatment G | Drug | Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition. |
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| Treatment H | Drug | Participants will receive oral dose of dapagliflozin capsule in fasted condition. |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From screening until follow-up visit (5 to 7 days post final dose) |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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