Heart FailurePhase 1NCT04798222

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

A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Heart Failure, run by AstraZeneca at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Heart Failure
What is being tested?: Treatment A, Treatment B and Treatment C
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteGermany
Study dates: 29 Jun 2021to 3 Sep 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy participants of non-childbearing potential with suitable veins for cannulation or repeated venipuncture at screening
Females must have a negative pregnancy test at the screening Visit and a negative urine pregnancy test at admission to the study center, must not be lactating and must be of non childbearing potential
Have a body mass index between 18 and 29.9 kg/m^2, inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive, at screening

Who cannot join

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results at screening, as judged by the Investigator
Any clinically significant abnormal findings in vital signs, and 12-lead electrocardiogram as judged by the Investigator
Any positive result on screening for serum hepatitis B surface antigen or anti-hemoglobin antibody, hepatitis C antibody, and human immunodeficiency virus antibody

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Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months (or 5 half lives, whichever is longer) of the first administration of IMP in this study
Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to AZD9977 or dapagliflozin
Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the 3 months prior to screening
Participant has a positive test result for Severe acute respiratory syndrome coronavirus 2 reverse transcriptase polymerase chain reaction at admission
Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP
Use of any prescribed or non prescribed medication including antacids, analgesics, hormone replacement therapy, herbal remedies, megadose vitamins and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half life
Participants who have previously received AZD9977 or dapagliflozin
Judgment by the Investigators that the participant should not participate in the study if they have any ongoing or recent minor medical complaints
Participants who cannot communicate reliably with the Investigator and/or is not able to read, speak and understand the German language
Participant has clinical signs and symptoms consistent with corona virus disease 2019 (COVID-19), or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on first admission
History of severe COVID-19 infection (hospitalization, extracorporeal membrane oxygenation, mechanically ventilated) as judged by the Investigator

Trial locations and contacts

1 site in 1 country.

Germany1 site

Research Site
Berlin, 14050

Other trials in Germany

About this study

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

Read the detailed 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:

Treatment A: AZD9977 Dose A + 10 mg dapagliflozin tablet, fasted
Treatment B: AZD9977 Dose A + 10 mg dapagliflozin capsule 1, fasted
Treatment C: AZD9977 Dose A + 10 mg dapagliflozin capsule 1, fed
Treatment D: AZD9977 Dose A + 10 mg dapagliflozin capsule 2, fasted
Treatment E: AZD9977 Dose A + 10 mg dapagliflozin capsule 2, fed
Treatment F: AZD9977 Dose A + 10 mg dapagliflozin capsule 3, fasted
Treatment G: AZD9977 Dose A + 10 mg dapagliflozin capsule 4, fasted
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.

Conditions: Heart Failure
Being tested: Treatment A, Treatment B, Treatment C, Treatment D, Treatment E
Keywords: Bioavailability, Oral selective mineralocorticoid receptor modulator, Pharmacokinetics, Dapagliflozin, AZD9977
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment ADrug
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition.
Treatment BDrug
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition.
Treatment CDrug
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition
Treatment DDrug
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition.
Treatment EDrug
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition.
Treatment FDrug
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition.
Treatment GDrug
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition.
Treatment HDrug
Participants will receive oral dose of dapagliflozin capsule in fasted condition.

Study groups in NCT04798222
Study group	Role	What they receive
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. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C; Drug: Treatment D; Drug: Treatment E
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. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C; Drug: Treatment D; Drug: Treatment E
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. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C; Drug: Treatment D; Drug: Treatment E
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. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C; Drug: Treatment D; Drug: Treatment E
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. Receives: Drug: Treatment A; Drug: Treatment F; Drug: Treatment G; Drug: Treatment H
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. Receives: Drug: Treatment A; Drug: Treatment F; Drug: Treatment G; Drug: Treatment H
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. Receives: Drug: Treatment A; Drug: Treatment F; Drug: Treatment G; Drug: Treatment H
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. Receives: Drug: Treatment A; Drug: Treatment F; Drug: Treatment G; Drug: Treatment H

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)

Secondary outcomes (13)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From screening until follow-up visit (5 to 7 days post final dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 20213 Sep 2021

First posted15 Mar 2021
Study start29 Jun 2021
Primary completion3 Sep 2021
Study completion3 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04798222
Sponsor's protocol ID: D6402C00003
Other IDs: 2021-000483-30
Status last verified: Sep 2021
First submitted: 11 Mar 2021
Last updated: 9 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04798222
Acronym / sponsor ID: D6402C00003
Conditions: Heart Failure
Keywords: Bioavailability, Oral selective mineralocorticoid receptor modulator, Pharmacokinetics, Dapagliflozin, AZD9977
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 29 Jun 2021 (actual)
Primary completion: 3 Sep 2021 (actual)
Study completion: 3 Sep 2021 (actual)
First posted: 15 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will be conducted at 2 study centers in Germany.

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:

Treatment A: AZD9977 Dose A + 10 mg dapagliflozin tablet, fasted
Treatment B: AZD9977 Dose A + 10 mg dapagliflozin capsule 1, fasted
Treatment C: AZD9977 Dose A + 10 mg dapagliflozin capsule 1, fed
Treatment D: AZD9977 Dose A + 10 mg dapagliflozin capsule 2, fasted
Treatment E: AZD9977 Dose A + 10 mg dapagliflozin capsule 2, fed
Treatment F: AZD9977 Dose A + 10 mg dapagliflozin capsule 3, fasted
Treatment G: AZD9977 Dose A + 10 mg dapagliflozin capsule 4, fasted
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 design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Group 1: Treatment Sequence ABECD	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment C, Drug: Treatment D, Drug: Treatment EParticipants 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.
Group 1: Treatment Sequence BACED	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment C, Drug: Treatment D, Drug: Treatment EParticipants 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.
Group 1: Treatment Sequence CDBEA	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment C, Drug: Treatment D, Drug: Treatment EParticipants 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.
Group 1: Treatment Sequence EADBC	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment C, Drug: Treatment D, Drug: Treatment EParticipants 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.
Group 2: Treatment Sequence AFHG	Experimental	Drug: Treatment A, Drug: Treatment F, Drug: Treatment G, Drug: Treatment HParticipants 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.
Group 2: Treatment Sequence FGAH	Experimental	Drug: Treatment A, Drug: Treatment F, Drug: Treatment G, Drug: Treatment HParticipants 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.
Group 2: Treatment Sequence GHFA	Experimental	Drug: Treatment A, Drug: Treatment F, Drug: Treatment G, Drug: Treatment HParticipants 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.
Group 2: Treatment Sequence HAGF	Experimental	Drug: Treatment A, Drug: Treatment F, Drug: Treatment G, Drug: Treatment HParticipants 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.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy participants of non-childbearing potential with suitable veins for cannulation or repeated venipuncture at screening
Females must have a negative pregnancy test at the screening Visit and a negative urine pregnancy test at admission to the study center, must not be lactating and must be of non childbearing potential
Have a body mass index between 18 and 29.9 kg/m^2, inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive, at screening

Key exclusion criteria (18 listed)

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results at screening, as judged by the Investigator
Any clinically significant abnormal findings in vital signs, and 12-lead electrocardiogram as judged by the Investigator

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment AParticipants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition.	Drug	Group 1: Treatment Sequence ABECD, Group 1: Treatment Sequence BACED, Group 1: Treatment Sequence CDBEA, Group 1: Treatment Sequence EADBC, Group 2: Treatment Sequence AFHG, Group 2: Treatment Sequence FGAH, Group 2: Treatment Sequence GHFA, Group 2: Treatment Sequence HAGF
Treatment BParticipants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition.	Drug	Group 1: Treatment Sequence ABECD, Group 1: Treatment Sequence BACED, Group 1: Treatment Sequence CDBEA, Group 1: Treatment Sequence EADBC
Treatment CParticipants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition	Drug	Group 1: Treatment Sequence ABECD, Group 1: Treatment Sequence BACED, Group 1: Treatment Sequence CDBEA, Group 1: Treatment Sequence EADBC
Treatment DParticipants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition.	Drug	Group 1: Treatment Sequence ABECD, Group 1: Treatment Sequence BACED, Group 1: Treatment Sequence CDBEA, Group 1: Treatment Sequence EADBC
Treatment EParticipants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition.	Drug	Group 1: Treatment Sequence ABECD, Group 1: Treatment Sequence BACED, Group 1: Treatment Sequence CDBEA, Group 1: Treatment Sequence EADBC
Treatment FParticipants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition.	Drug	Group 2: Treatment Sequence AFHG, Group 2: Treatment Sequence FGAH, Group 2: Treatment Sequence GHFA, Group 2: Treatment Sequence HAGF
Treatment GParticipants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition.	Drug	Group 2: Treatment Sequence AFHG, Group 2: Treatment Sequence FGAH, Group 2: Treatment Sequence GHFA, Group 2: Treatment Sequence HAGF
Treatment HParticipants will receive oral dose of dapagliflozin capsule in fasted condition.	Drug	Group 2: Treatment Sequence AFHG, Group 2: Treatment Sequence FGAH, Group 2: Treatment Sequence GHFA, Group 2: Treatment Sequence HAGF

Primary outcome

Area under plasma concentration time curve from zero to infinity (AUCinf)
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)
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.
Area under the plasma concentration time curve from zero to the last quantifiable concentration (AUClast)
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)
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.
Maximum observed plasma (peak) drug concentration (Cmax)
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)
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.
Drug concentration in plasma at 24 hours post-dose (C24)
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)
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.

13 secondary outcomes

AUCinf of AZD9977 and dapagliflozin
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: From screening until follow-up visit (5 to 7 days post final dose)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
Individual participant dataSharing planned: Yes. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ozan Dursun principal investigator

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

Alen Jambrecina principal investigator

CTC North GmbH & Co. KG Martinistrasse 64 20251 Hamburg Germany

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Heart Failure, run by AstraZeneca at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under plasma concentration time curve from zero to infinity (AUCinf) (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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04798222.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.