NCT07404137

A Study to Investigate the Concentrations of Zibotentan and Dapagliflozin in Blood When Given With and Without Food

A Randomized, Single Dose, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Single Dose, Orally Administered, Combined Zibotentan/Dapagliflozin in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase I, open-label, randomized, 2-period, 2-treatment, crossover study in healthy participants. This study will measure the impact of food on the pharmacokinetics (PK) of combined zibotentan/dapagliflozin for the to be marketed fixed-dose combination (FDC) formulation (study intervention). The study will comprise of, (i) A screening period (ii) 2 treatment periods (iii) A final follow-up visit. All participants will receive a single dose of the study intervention once under fasted condition (Treatment A) and once under fed condition (Treatment B).

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Zibotentan/Dapagliflozin FDC	Zibotentan/Dapagliflozin FDC will be administered as an oral tablet.

Timeline

• Start date: 2026-02-16
• Primary completion: 2026-04-02
• Completion: 2026-04-02
• First posted: 2026-02-11
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study