Study to collect samples for MIST analysis of Zibotentan and bioavailability of Zibotentan and Dapagliflozin in heatlhy participants
Study identifier:D4325C00003
ClinicalTrials.gov identifier:NCT04991571
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Chronic Kidney Disease
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Zibotentan (Treatment A), Dapagliflozin (Treatment A), Zibotentan/Dapagliflozin – Formulation 1 (Treatment B), Zibotentan/Dapagliflozin – Formulation 2 (Treatment C)
Sex
All
Actual Enrollment
27
Study type
Interventional
Age
18 Years - 50 Years
Date
Study Start Date: 29 Jul 2021
Primary Completion Date: 22 Oct 2021
Study Completion Date: 22 Oct 2021
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2022 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Part 1 Participants will be administered with zibotentan once daily for 5 days. | Drug: Zibotentan (Treatment A) Zibotentan capsule will be administered orally as multiple doses in Part 1 and as single dose in Part 2. |
| Experimental: Part 2: Treatment Sequence ABC 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. | Drug: Zibotentan (Treatment A) Zibotentan capsule will be administered orally as multiple doses in Part 1 and as single dose in Part 2. Drug: Dapagliflozin (Treatment A) Dapagliflozin tablet will be administered orally as single dose in Part 2. Drug: Zibotentan/Dapagliflozin – Formulation 1 (Treatment B) Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2. Drug: Zibotentan/Dapagliflozin – Formulation 2 (Treatment C) Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2. |
| Experimental: Part 2: Treatment Sequence BCA 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. | Drug: Zibotentan (Treatment A) Zibotentan capsule will be administered orally as multiple doses in Part 1 and as single dose in Part 2. Drug: Dapagliflozin (Treatment A) Dapagliflozin tablet will be administered orally as single dose in Part 2. Drug: Zibotentan/Dapagliflozin – Formulation 1 (Treatment B) Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2. Drug: Zibotentan/Dapagliflozin – Formulation 2 (Treatment C) Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2. |
| Experimental: Part 2: Treatment Sequence CAB 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. | Drug: Zibotentan (Treatment A) Zibotentan capsule will be administered orally as multiple doses in Part 1 and as single dose in Part 2. Drug: Dapagliflozin (Treatment A) Dapagliflozin tablet will be administered orally as single dose in Part 2. Drug: Zibotentan/Dapagliflozin – Formulation 1 (Treatment B) Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2. Drug: Zibotentan/Dapagliflozin – Formulation 2 (Treatment C) Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2. |
