NCT07404137

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 16, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

February 5, 2026

Last Update Submit

April 10, 2026

Conditions

Healthy Participants

Keywords

Chronic kidney diseasePharmacokineticsFood effectFixed-dose combination

Outcome Measures

Primary Outcomes (3)

  • Area under concentration-time curve from time 0 to infinity (AUCinf)

    To investigate the effect of a high fat, high calorie meal, in comparison to fasting conditions, on the PK of zibotentan/dapagliflozin FDC after a single oral dose in healthy participants.

    At predefined intervals from Day 1 to Day 4 for both treatment periods

  • Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

    To investigate the effect of a high fat, high calorie meal, in comparison to fasting conditions, on the PK of zibotentan/dapagliflozin FDC after a single oral dose in healthy participants.

    At predefined intervals from Day 1 to Day 4 for both treatment periods

  • Maximum observed drug concentration (Cmax)

    To investigate the effect of a high fat, high calorie meal, in comparison to fasting conditions, on the PK of zibotentan/dapagliflozin FDC after a single oral dose in healthy participants.

    At predefined intervals from Day 1 to Day 4 for both treatment periods

Secondary Outcomes (5)

  • Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Up to end of study visit, for a total of approximately 5 weeks

  • Apparent total body clearance (CL/F)

    At predefined intervals from Day 1 to Day 4 for both treatment periods

  • Apparent volume of distribution based on the terminal phase (Vz/F)

    At predefined intervals from Day 1 to Day 4 for both treatment periods

  • Time to reach maximum observed concentration (tmax)

    At predefined intervals from Day 1 to Day 4 for both treatment periods

  • Terminal elimination half-life (t½λz)

    At predefined intervals from Day 1 to Day 4 for both treatment periods

Study Arms (2)

Treatment AB

EXPERIMENTAL

Participants will receive single dose of Zibotentan/Dapagliflozin FDC after an overnight fast of at least 10 hours (Treatment A). After a washout period, participants will receive another single dose of Zibotentan/Dapagliflozin FDC 30 minutes after having a high-fat, high-calorie standardized meal (Treatment B).

Drug: Zibotentan/Dapagliflozin FDC

Treatment BA

EXPERIMENTAL

Participants will receive single dose of Zibotentan/Dapagliflozin FDC 30 minutes after having a high-fat high-calorie standardized meal (Treatment B). After a washout period, participants will receive another single dose of Zibotentan/Dapagliflozin FDC after an overnight fast of at least 10 hours (Treatment A).

Drug: Zibotentan/Dapagliflozin FDC

Interventions

Zibotentan/Dapagliflozin FDCDRUG

Zibotentan/Dapagliflozin FDC will be administered as an oral tablet.

Treatment ABTreatment BA

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female of non-childbearing potential. Participants with suitable veins for cannulation or repeated venipuncture.
  • Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg (inclusive) at Screening.

You may not qualify if:

  • History of any clinically important disease or disorder.
  • History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • Any clinically important illness, medical/surgical procedure, or trauma.
  • Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results or other laboratory values or vital signs.
  • Any positive result on screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C virus (HCV) antibody, or Human immunodeficiency virus (HIV) (Type 1 and 2) antibodies.
  • Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
  • History or ongoing allergy/hypersensitivity, to Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i- eg, dapagliflozin, empagliflozin), or zibotentan or other Endothelin Receptor Antagonist (ERAs- eg, ambrisentan, atrasentan,bosentan), or any of the excipients in the zibotentan/dapagliflozin tablets.
  • Participants who have previously received zibotentan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

ZD4054

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 11, 2026

Study Start

February 16, 2026

Primary Completion

April 2, 2026

Study Completion

April 2, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

US(1)