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

NCT04991571 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2021-11-23

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-29
Primary Completion
2021-10-22
Completion
2021-10-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04991571 on ClinicalTrials.gov