Status:
COMPLETED
Study to Assess the Bioavailability of Different Formulations of AZD9977 and Dapagliflozin and Influence of Food in Selected Formulations in Healthy Volunteers
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Heart Failure
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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 formulation...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
June 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04798222
Start Date
June 29 2021
End Date
September 3 2021
Last Update
September 9 2021
Active Locations (1)
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1
Research Site
Berlin, Germany, 14050