NCT04991571

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-29
• Primary completion: 2021-10-22
• Completion: 2021-10-22
• First posted: 2021-08-05
• Last updated: 2021-11-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study