Study to Collect Samples for MIST Analysis of Zibotentan and Bioavailability of Zibotentan and Dapagliflozin in Heatlhy Participants
Chronic Kidney Disease
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
For inclusion in the study participants should fulfil the following criteria:
- Participants with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at the Screening Visit and within 24 hours prior to dosing, must not be lactating and must be of non- childbearing potential
- Male participant must adhere to the contraception methods.
- Have a BMI between 18 and 29.9 kg/m^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
- Provision of signed and dated, written informed consent prior to any study specific procedures.
Exclusion Criteria:
Participants will not enter the study if any of the following exclusion criteria are fulfilled:
- History or presence of gastrointestinal, hepatic or renal disease or any important disease or disorder.
- Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention.
- Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and Human immunodeficiency virus antibody.
- Abnormal vital signs. 6 History of drug abuse or alcohol abuse.
7. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
8. Participants who are vegans or have medical dietary restrictions. 9. Participants tested positive for COVID-19 at the time of randomisation or have been previously hospitalised with COVID-19 infection.
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Part 1
Part 2: Treatment Sequence ABC
Part 2: Treatment Sequence BCA
Part 2: Treatment Sequence CAB
Participants will be administered with zibotentan once daily for 5 days.
Each participant will receive 3 single-dose treatments of zibotentan and dapagliflozin (Treatment A; Treatment B; Treatment C) in 3 treatment periods, separated by a washout period of at least 7 days between treatment periods.
Each participant will receive 3 single-dose treatments of zibotentan and dapagliflozin (Treatment B; Treatment C; Treatment A) in 3 treatment periods, separated by a washout period of at least 7 days between treatment periods.
Each participant will receive 3 single-dose treatments of zibotentan and dapagliflozin (Treatment C; Treatment A; Treatment B) in 3 treatment periods, separated by a washout period of at least 7 days between treatment periods.