A Study to Investigate the Concentrations of Zibotentan and Dapagliflozin in Blood When Given Wit… (NCT07404137) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Concentrations of Zibotentan and Dapagliflozin in Blood When Given With and Without Food
United States26 participantsStarted 2026-02-16
Plain-language summary
The purpose of this study is to investigate the concentrations of zibotentan and dapagliflozin in blood when given with and without food in healthy participants.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Healthy male and/or female of non-childbearing potential. Participants with suitable veins for cannulation or repeated venipuncture.
* Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg (inclusive) at Screening.
Exclusion Criteria:
* History of any clinically important disease or disorder.
* 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 important illness, medical/surgical procedure, or trauma.
* Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results or other laboratory values or vital signs.
* Any positive result on screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C virus (HCV) antibody, or Human immunodeficiency virus (HIV) (Type 1 and 2) antibodies.
* Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
* History or ongoing allergy/hypersensitivity, to Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i- eg, dapagliflozin, empagliflozin), or zibotentan or other Endothelin Receptor Antagonist (ERAs- eg, ambrisentan, atrasentan,bosentan), or any of the excipients in the zibotentan/dapagliflozin tablets.
* Participants who have previously received zibotentan.
What they're measuring
1
Area under concentration-time curve from time 0 to infinity (AUCinf)
Timeframe: At predefined intervals from Day 1 to Day 4 for both treatment periods
2
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Timeframe: At predefined intervals from Day 1 to Day 4 for both treatment periods
3
Maximum observed drug concentration (Cmax)
Timeframe: At predefined intervals from Day 1 to Day 4 for both treatment periods