Healthy ParticipantsPhase 1NCT06979388
A Study to Investigate the Effect of Food on Balcinrenone/Dapagliflozin Pharmacokinetics in Fed and Fasted State and Pharmacokinetics of Balcinrenone When Dosed With a P-gp Inhibitor in Healthy Participants.
A Phase 1 study testing balcinrenone/ dapagliflozin and quinidine in people with Healthy Participants, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The main purpose of this study is to assess the effect of food on balcinrenone/ dapagliflozin pharmacokinetics in fed and fasted state and pharmacokinetics of balcinrenone when dosed with a P-gp inhibitor in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- balcinrenone/ dapagliflozin and quinidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 May 2025to 12 Jul 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Main Inclusion Criteria:
- Have a Body Mass Index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
- All females of childbearing potential must have a negative pregnancy test.
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
Main Exclusion Criteria:
- History of any clinically important disease or disorder which may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study
- 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/major surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Any clinically important abnormalities in clinical chemistry, haematology, urinalysis or vital signs.
- Positive result for serum hepatitis B surface antigen, hepatitis C antibody, and HIV antibody
- History of long QT syndrome or history of additional risk factors for QT prolongation - for example a family history of long QT syndrome or the use of concomitant medications known to prolong the QT/QTc interval. Any clinically significant abnormalities on 12-lead ECG at the Screening Visit, as judged by the investigator, including but not limited to any significant arrythmia, conduction abnormalities, and/or prolonged QTcF > 450 ms.
- Current smokers or those who have smoked or used nicotine products within the previous 3 months prior to Screening Visit.
- History of alcohol or drug abuse. Positive screen for drugs of abuse, alcohol or cotinine.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
- History of hypersensitivity to drugs with a similar chemical structure or class to balcinrenone, dapagliflozin and quinidine. Any contraindications listed for dapagliflozin and quinidine.
- Use of drugs with enzyme inducing properties within 3 weeks prior to the first administration of study intervention.
- Use of any prescribed or nonprescribed medication, herbal remedies or intake of > 3 × daily recommended levels of vitamins and minerals during the 2 weeks prior to the first administration of study intervention
- Plasma donation within one month of screening or any blood donation/blood loss > 500 mL during the 3 months prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomised, Single-dose, Open-label, 3-period, 3-treatment, 3-way Crossover Study to Assess the Effect of Food on Balcinrenone/Dapagliflozin Pharmacokinetics in Fed and Fasted State and Pharmacokinetics of Balcinrenone When Dosed With a P-gp Inhibitor in Healthy Participants.
The main purpose of this study is to assess the effect of food on balcinrenone/ dapagliflozin pharmacokinetics in fed and fasted state and pharmacokinetics of balcinrenone when dosed with a P-gp inhibitor in healthy participants.
Read the detailed description
This study will be an open-label, randomised, 3-period, 3-treatment, single-dose, 3-way crossover study in healthy participants (males and females), performed at a single study site.
The study comprises of:
- Screening period of 4 weeks within the interval of Day -28 and Day -2.
- Three treatment periods during which participants will be residing at the Clinical Unit from the day before the first study intervention administration (Day -1). The participant will be discharged on Day 10.
- Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule dosed in the fasted state.
- Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food.
- Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule (dosed together with a P-gp inhibitor tablets (quinidine) in fasted state.
Participants will be randomised on Day 1 to one of the following 6 treatment sequences: ABC, ACB, BCA, BAC, CAB, or CBA. Each participant will receive all 3 treatments (A, B, and C) in the sequence participant was randomised to. Each treatment will be separated by a washout period of 72 hours; thus, each participant will receive study intervention on Day 1, Day 4, and Day 7.
- A final Follow-up Call within 5 - 7 days (Day 12-14) after the last study intervention administration.
- Conditions
- Healthy Participants
- Being tested
- balcinrenone/ dapagliflozin, quinidine
- Keywords
- Food effect, Mineralocorticoid receptor modulator, P-glycoprotein inhibitor, Fed and fasted state, Standardised high-fat and high-calorie meal
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balcinrenone/ dapagliflozinDrug
Participants will be receiving balcinrenone/ dapagliflozine in fasted or fed condition.
quinidineDrug
Participants will be receiving quinidine orally in fasted condition.
| Study group | Role | What they receive |
|---|---|---|
| Treatment ABC | Experimental | Participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule on Day 1 and then followed by a washout period of 72 hours. On Day 4, participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food, followed by a washout period of 72 hours. On Day 7, participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively). Receives: Drug: balcinrenone/ dapagliflozin; Drug: quinidine |
| Treatment ACB | Experimental | The participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule on Day 1 and then followed by washout period of 72 hours. On Day 4, participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 7, participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food. Receives: Drug: balcinrenone/ dapagliflozin; Drug: quinidine |
| Treatment BCA | Experimental | The participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food on Day 1 and then followed by washout period of 72 hours. On Day 4, participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 7, participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule. Receives: Drug: balcinrenone/ dapagliflozin; Drug: quinidine |
| Treatment BAC | Experimental | The participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food on Day 1 and then followed by washout period of 72 hours. On Day 4, participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule and then followed by washout period of 72 hours. On Day 7 participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively). Receives: Drug: balcinrenone/ dapagliflozin; Drug: quinidine |
| Treatment CAB | Experimental | The participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 4, participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule and then followed by washout period of 72 hours. On Day 7, participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food. Receives: Drug: balcinrenone/ dapagliflozin; Drug: quinidine |
| Treatment CBA | Experimental | The participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 4, participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food, followed by a washout period of 72 hours. On Day 7, participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule. Receives: Drug: balcinrenone/ dapagliflozin; Drug: quinidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under concentration-time curve from time zero to infinity (AUCinf)
Measured: From Day 1 to Day 10
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Measured: From Day 1 to Day 10
Maximum observed drug concentration (Cmax)
Measured: From Day 1 to Day 10
Terminal elimination half-life (t1/2λz)
Measured: From Day 1 to Day 10
Time to reach maximum observed concentration (tmax)
Measured: From Day 1 to Day 10
Apparent volume of distribution based on the terminal phase (Vz/F)
Measured: From Day 1 to Day 10
Apparent total body clearance (CL/F)
Measured: From Day 1 to Day 10
Renal Clearance (CLR) (balcinrenone only)
Measured: From Day 1 to Day 10
Drug concentration in plasma at 24 hours post-dose (C24)
Measured: From Day 1 to Day 10
Secondary outcomes (1)
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Measured: From Screening (Day -28 to Day -2) until Follow-up (Day 12 to Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2025
- Study start20 May 2025
- Primary completion12 Jul 2025
- Study completion12 Jul 2025
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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979388
- Sponsor's protocol ID
- D6402C00009
- Other IDs
- 1011789
- Status last verified
- Aug 2025
- First submitted
- 5 May 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Single-dose, Open-label, 3-period, 3-treatment, 3-way Crossover Study to Assess the Effect of Food on Balcinrenone/Dapagliflozin Pharmacokinetics in Fed and Fasted State and Pharmacokinetics of Balcinrenone When Dosed With a P-gp Inhibitor in Healthy Participants.
- ClinicalTrials.gov ID
- NCT06979388
- Acronym / sponsor ID
- D6402C00009
- Conditions
- Healthy Participants
- Keywords
- Food effect, Mineralocorticoid receptor modulator, P-glycoprotein inhibitor, Fed and fasted state, Standardised high-fat and high-calorie meal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 20 May 2025 (actual)
- Primary completion
- 12 Jul 2025 (actual)
- Study completion
- 12 Jul 2025 (actual)
- First posted
- 19 May 2025 (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 main purpose of this study is to assess the effect of food on balcinrenone/ dapagliflozin pharmacokinetics in fed and fasted state and pharmacokinetics of balcinrenone when dosed with a P-gp inhibitor in healthy participants.
Detailed description
This study will be an open-label, randomised, 3-period, 3-treatment, single-dose, 3-way crossover study in healthy participants (males and females), performed at a single study site.
The study comprises of:
- Screening period of 4 weeks within the interval of Day -28 and Day -2.
- Three treatment periods during which participants will be residing at the Clinical Unit from the day before the first study intervention administration (Day -1). The participant will be discharged on Day 10.
- Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule dosed in the fasted state.
- Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food.
- Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule (dosed together with a P-gp inhibitor tablets (quinidine) in fasted state.
Participants will be randomised on Day 1 to one of the following 6 treatment sequences: ABC, ACB, BCA, BAC, CAB, or CBA. Each participant will receive all 3 treatments (A, B, and C) in the sequence participant was randomised to. Each treatment will be separated by a washout period of 72 hours; thus, each participant will receive study intervention on Day 1, Day 4, and Day 7.
- A final Follow-up Call within 5 - 7 days (Day 12-14) after the last study intervention administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment ABC | Experimental | Drug: balcinrenone/ dapagliflozin, Drug: quinidineParticipants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule on Day 1 and then followed by a washout period of 72 hours. On Day 4, participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food, followed by a washout period of 72 hours. On Day 7, participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively). |
| Treatment ACB | Experimental | Drug: balcinrenone/ dapagliflozin, Drug: quinidineThe participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule on Day 1 and then followed by washout period of 72 hours. On Day 4, participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 7, participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food. |
| Treatment BCA | Experimental | Drug: balcinrenone/ dapagliflozin, Drug: quinidineThe participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food on Day 1 and then followed by washout period of 72 hours. On Day 4, participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 7, participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule. |
| Treatment BAC | Experimental | Drug: balcinrenone/ dapagliflozin, Drug: quinidineThe participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food on Day 1 and then followed by washout period of 72 hours. On Day 4, participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule and then followed by washout period of 72 hours. On Day 7 participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively). |
| Treatment CAB | Experimental | Drug: balcinrenone/ dapagliflozin, Drug: quinidineThe participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 4, participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule and then followed by washout period of 72 hours. On Day 7, participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food. |
| Treatment CBA | Experimental | Drug: balcinrenone/ dapagliflozin, Drug: quinidineThe participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 4, participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food, followed by a washout period of 72 hours. On Day 7, participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| balcinrenone/ dapagliflozinParticipants will be receiving balcinrenone/ dapagliflozine in fasted or fed condition. | Drug | Treatment ABC, Treatment ACB, Treatment BAC, Treatment BCA, Treatment CAB, Treatment CBA |
| quinidineParticipants will be receiving quinidine orally in fasted condition. | Drug | Treatment ABC, Treatment ACB, Treatment BAC, Treatment BCA, Treatment CAB, Treatment CBA |
Primary outcome
Area under concentration-time curve from time zero to infinity (AUCinf)
Time frame: From Day 1 to Day 10
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: From Day 1 to Day 10
Maximum observed drug concentration (Cmax)
Time frame: From Day 1 to Day 10
Terminal elimination half-life (t1/2λz)
Time frame: From Day 1 to Day 10
Time to reach maximum observed concentration (tmax)
Time frame: From Day 1 to Day 10
Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: From Day 1 to Day 10
Apparent total body clearance (CL/F)
Time frame: From Day 1 to Day 10
Renal Clearance (CLR) (balcinrenone only)
Time frame: From Day 1 to Day 10
Drug concentration in plasma at 24 hours post-dose (C24)
Time frame: From Day 1 to Day 10
1 secondary outcome
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: From Screening (Day -28 to Day -2) until Follow-up (Day 12 to Day 14)
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 12 Aug 2025.
- 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 balcinrenone/ dapagliflozin and quinidine in people with Healthy Participants, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Aug 2025. 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 Kingdom. 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 zero to infinity (AUCinf) (time frame: From Day 1 to Day 10). The study lists 9 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 12 Aug 2025.