Study to Assess the Bioavailability of Different Formulations of AZD9977 and Dapagliflozin and Influence of Food in Selected Formulations in Healthy Volunteers
NCT ID: NCT04798222
Last Updated: 2021-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2021-06-29
2021-09-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess the Reaction of Body for Four Different Formulations of AZD9977 (Part A) and Influence of Food and Lower Dose of a Selected Formulation (Part B) in Healthy Male Subjects
NCT03804645
Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease
NCT04595370
Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation
NCT04792190
Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack.
NCT04564742
A Phase 1 Study to Assess the Pharmacokinetics of AZD9977 Administered Alone and in Combination With Itraconazole in Healthy Volunteers
NCT03843060
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1: Treatment Sequence ABECD
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.
Treatment A
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition.
Treatment B
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition.
Treatment C
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition
Treatment D
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition.
Treatment E
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition.
Group 1: Treatment Sequence BACED
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.
Treatment A
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition.
Treatment B
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition.
Treatment C
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition
Treatment D
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition.
Treatment E
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition.
Group 1: Treatment Sequence CDBEA
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.
Treatment A
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition.
Treatment B
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition.
Treatment C
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition
Treatment D
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition.
Treatment E
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition.
Group 1: Treatment Sequence EADBC
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.
Treatment A
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition.
Treatment B
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition.
Treatment C
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition
Treatment D
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition.
Treatment E
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition.
Group 2: Treatment Sequence AFHG
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.
Treatment A
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition.
Treatment F
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition.
Treatment G
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition.
Treatment H
Participants will receive oral dose of dapagliflozin capsule in fasted condition.
Group 2: Treatment Sequence FGAH
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.
Treatment A
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition.
Treatment F
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition.
Treatment G
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition.
Treatment H
Participants will receive oral dose of dapagliflozin capsule in fasted condition.
Group 2: Treatment Sequence GHFA
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.
Treatment A
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition.
Treatment F
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition.
Treatment G
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition.
Treatment H
Participants will receive oral dose of dapagliflozin capsule in fasted condition.
Group 2: Treatment Sequence HAGF
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.
Treatment A
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition.
Treatment F
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition.
Treatment G
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition.
Treatment H
Participants will receive oral dose of dapagliflozin capsule in fasted condition.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Treatment A
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition.
Treatment B
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition.
Treatment C
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition
Treatment D
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition.
Treatment E
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition.
Treatment F
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition.
Treatment G
Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition.
Treatment H
Participants will receive oral dose of dapagliflozin capsule in fasted condition.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ozan Dursun
Role: PRINCIPAL_INVESTIGATOR
Parexel Early Phase Clinical Unit Berlin Campus DRK Kliniken Berlin Westend, Haus 31 Spandauer Damm 130 14050 Berlin Germany
Alen Jambrecina
Role: PRINCIPAL_INVESTIGATOR
CTC North GmbH & Co. KG Martinistrasse 64 20251 Hamburg Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Berlin, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-000483-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D6402C00003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.