Healthy ParticipantsPhase 1NCT07404137
A Study to Investigate the Concentrations of Zibotentan and Dapagliflozin in Blood When Given With and Without Food
A Phase 1 study testing Zibotentan/Dapagliflozin FDC in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Zibotentan/Dapagliflozin FDC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2026to 2 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Zibotentan/Dapagliflozin FDC
- Keywords
- Chronic kidney disease, Pharmacokinetics, Food effect, Fixed-dose combination
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zibotentan/Dapagliflozin FDCDrug
Zibotentan/Dapagliflozin FDC will be administered as an oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Zibotentan/Dapagliflozin FDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
To further assess the safety and tolerability of single doses of zibotentan/dapagliflozin FDC in healthy participants.
Measured: Up to end of study visit, for a total of approximately 5 weeks
Apparent total body clearance (CL/F)
To further evaluate the PK of zibotentan/dapagliflozin FDC after a single oral dose in healthy participants.
Measured: At predefined intervals from Day 1 to Day 4 for both treatment periods
Apparent volume of distribution based on the terminal phase (Vz/F)
To further evaluate the PK of zibotentan/dapagliflozin FDC after a single oral dose in healthy participants.
Measured: At predefined intervals from Day 1 to Day 4 for both treatment periods
Time to reach maximum observed concentration (tmax)
To further evaluate the PK of zibotentan/dapagliflozin FDC after a single oral dose in healthy participants.
Measured: At predefined intervals from Day 1 to Day 4 for both treatment periods
Terminal elimination half-life (t½λz)
To further evaluate the PK of zibotentan/dapagliflozin FDC after a single oral dose in healthy participants.
Measured: At predefined intervals from Day 1 to Day 4 for both treatment periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start16 Feb 2026
- Primary completion2 Apr 2026
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404137
- Sponsor's protocol ID
- D4327C00003
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07404137
- Acronym / sponsor ID
- D4327C00003
- Conditions
- Healthy Participants
- Keywords
- Chronic kidney disease, Pharmacokinetics, Food effect, Fixed-dose combination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment AB | Experimental | Drug: Zibotentan/Dapagliflozin FDCParticipants 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). |
| Treatment BA | Experimental | Drug: Zibotentan/Dapagliflozin FDCParticipants 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zibotentan/Dapagliflozin FDCZibotentan/Dapagliflozin FDC will be administered as an oral tablet. | Drug | Treatment AB, Treatment BA |
Primary outcome
Area under concentration-time curve from time 0 to infinity (AUCinf)
Time frame: At predefined intervals from Day 1 to Day 4 for both treatment periods
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.
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: At predefined intervals from Day 1 to Day 4 for both treatment periods
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.
Maximum observed drug concentration (Cmax)
Time frame: At predefined intervals from Day 1 to Day 4 for both treatment periods
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.
5 secondary outcomes
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to end of study visit, for a total of approximately 5 weeks
Apparent total body clearance (CL/F)
Time frame: At predefined intervals from Day 1 to Day 4 for both treatment periods
Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: At predefined intervals from Day 1 to Day 4 for both treatment periods
Time to reach maximum observed concentration (tmax)
Time frame: At predefined intervals from Day 1 to Day 4 for both treatment periods
Terminal elimination half-life (t½λz)
Time frame: At predefined intervals from Day 1 to Day 4 for both treatment periods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zibotentan/Dapagliflozin FDC in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under concentration-time curve from time 0 to infinity (AUCinf) (time frame: At predefined intervals from Day 1 to Day 4 for both treatment periods). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.