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Clinical Trial Details

Trial ID: L0300
Source ID: NCT04991571
Associated Drug: Zibotentan (Treatment A)
Title: Study to Collect Samples for MIST Analysis of Zibotentan and Bioavailability of Zibotentan and Dapagliflozin in Heatlhy Participants
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: Zibotentan (Treatment A)|DRUG: Dapagliflozin (Treatment A)|DRUG: Zibotentan/Dapagliflozin - Formulation 1 (Treatment B)|DRUG: Zibotentan/Dapagliflozin - Formulation 2 (Treatment C)
Outcome Measures: Primary: Part 1: Metabolites in Safety Testing sampling, Plasma sample will be collected to understand the PK profiling of zibotentan metabolites and to meet the regulatory requirements., Day 1 through Day 6 (pre-dose, 30 min; 1, 2, 4, 6, 8, 12 and 24 hours post dose)|Part 2: Area under plasma concentration time curve from zero to infinity (AUCinf), Relative bioavailability of zibotentan and dapagliflozin after dosing with two different FDC formulations and dosing with separate formulations of zibotentan and dapagliflozin will be evaluated., Day 1 through Day 3 of each treatment period|Part 2: Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast), Relative bioavailability of zibotentan and dapagliflozin after dosing with two different FDC formulations and dosing with separate formulations of zibotentan and dapagliflozin will be evaluated., Day 1 through Day 3 of each treatment period|Part 2: Maximum observed plasma drug concentration (Cmax), Relative bioavailability of zibotentan and dapagliflozin after dosing with two different FDC formulations and dosing with separate formulations of zibotentan and dapagliflozin will be evaluated., Day 1 through Day 3 of each treatment period|Part 2: Observed concentration at 24 hours post-dose (C24), Relative bioavailability of zibotentan and dapagliflozin after dosing with two different FDC formulations and dosing with separate formulations of zibotentan and dapagliflozin will be evaluated., Day 1 through Day 3 of each treatment period | Secondary: Part 2: Time to reach peak or maximum observed concentration (tmax), Relative bioavailability of zibotentan and dapagliflozin after dosing with two different FDC formulations and dosing with separate formulations of zibotentan and dapagliflozin will be evaluated., Day 1 through Day 3 of each treatment period|Part 2: Terminal rate constant (λz), Relative bioavailability of zibotentan and dapagliflozin after dosing with two different FDC formulations and dosing with separate formulations of zibotentan and dapagliflozin will be evaluated., Day 1 through Day 3 of each treatment period|Part 2: Half life associated with λz (t½λz), Relative bioavailability of zibotentan and dapagliflozin after dosing with two different FDC formulations and dosing with separate formulations of zibotentan and dapagliflozin will be evaluated., Day 1 through Day 3 of each treatment period|Part 2: Apparent total body clearance of drug from plasma after extravascular administration (CL/F), Relative bioavailability of zibotentan and dapagliflozin after dosing with two different FDC formulations and dosing with separate formulations of zibotentan and dapagliflozin will be evaluated., Day 1 through Day 3 of each treatment period|Part 2: Volume of distribution at steady state following extravascular administration (Vz/F), Relative bioavailability of zibotentan and dapagliflozin after dosing with two different FDC formulations and dosing with separate formulations of zibotentan and dapagliflozin will be evaluated., Day 1 through Day 3 of each treatment period|Part 1 and Part 2: Number of adverse events and serious adverse events, Safety and tolerability of zibotentan and dapagliflozin will be studied., From Sceerning to Follow-up Visit approximately 40 days for Part 1 and 49 days for Part 2
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 27
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-07-29
Completion Date: 2021-10-22
Results First Posted:
Last Update Posted: 2021-11-23
Locations: Research Site, Brooklyn, Maryland, 21225, United States
URL: https://clinicaltrials.gov/show/NCT04991571