Study to Collect Samples for MIST Analysis of Zibotentan and Bioavailability of Zibotentan and Dapagliflozin in Heatlhy Participants

Completed · Phase 1

Conditions studied: Chronic Kidney Disease

In brief

The study will have 2 independent parts: Part 1 of the study is intended to collect samples for Metabolites in Safety Testing (MIST) analysis after administration of multiple doses of zibotentan. Part 2 of the study is designed to evaluate the relative bioavailability of zibotentan and dapagliflozin after dosing with two different fixed-dose combination (FDC) formulations and dosing with separate formulations of zibotentan and dapagliflozin.

Key facts

Study ID

NCT04991571

Run by

AstraZeneca

People needed

27

Starts

2021-07-29

Expected to finish

2021-10-22

Last updated by the study team

2021-11-23

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
• 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.

Where it is running

• Research Site — Brooklyn, Maryland, United States

Full record on ClinicalTrials.gov

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