Research Site
Brooklyn, Maryland, 21225, United States
NCT Number: NCT04991571
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.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 1
Brooklyn, Maryland, 21225, United States
Part 1 will be an open-label, non-randomised, single treatment period. A single treatment period during which participants will be resident at the study centre from 2 days before dosing (Day -2) until the morning of Day 6.
Part 2 will be an open-label, randomised, 3-period, 3-treatment, cross-over single dose study. Participants will be randomised to one of 3 treatment sequences and will receive 3 single-dose study interventions. Participants will be resident at the study centre from 2 days before dosing (Day -2) until Day 3 of the last treatment sequence.
Participants who were enrolled in Part 1 may not be enrolled in Part 2.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For inclusion in the study participants should fulfil the following criteria:
Exclusion criteria
Participants will not enter the study if any of the following exclusion criteria are fulfilled:
Zibotentan capsule will be administered orally as multiple doses in Part 1 and as single dose in Part 2.
Dapagliflozin tablet will be administered orally as single dose in Part 2.
Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2.
Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2.
Time frame: Day 1 through Day 6 (pre-dose, 30 min; 1, 2, 4, 6, 8, 12 and 24 hours post dose)
Plasma sample will be collected to understand the PK profiling of zibotentan metabolites and to meet the regulatory requirements.
Time frame: Day 1 through Day 3 of each treatment period
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.
Time frame: Day 1 through Day 3 of each treatment period
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.
Time frame: Day 1 through Day 3 of each treatment period
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.
Time frame: Day 1 through Day 3 of each treatment period
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.
Time frame: Day 1 through Day 3 of each treatment period
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.
Time frame: Day 1 through Day 3 of each treatment period
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.
Time frame: Day 1 through Day 3 of each treatment period
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.
Time frame: Day 1 through Day 3 of each treatment period
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.
Time frame: Day 1 through Day 3 of each treatment period
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.
Time frame: From Sceerning to Follow-up Visit approximately 40 days for Part 1 and 49 days for Part 2
Safety and tolerability of zibotentan and dapagliflozin will be studied.
AstraZeneca
Industry
A Phase 1, Open-label Study With Two Independent Parts: Collecting Samples for Metabolites in Safety Testing Analysis of Zibotentan After Repeated Administration (Part 1); and a Randomised, Cross-over, Three Period, Three-treatment, Single Dose Study to Assess the Relative Bioavailability of Different Formulations of Zibotentan and Dapagliflozin (Part 2) in Healthy Adult Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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