Healthy VolunteerPhase 1NCT06651021
A Phase I PK Study of Balcinrenone/Dapagliflozin in Healthy Chinese Participants
A Phase 1 study testing balcinrenone/dapagliflozin in people with Healthy Volunteer, run by AstraZeneca at 1 site in China.
Trial summary
This study is intended to evaluate the PK, safety, and tolerability of balcinrenone/dapagliflozin given as a single dose capsule to healthy Chinese participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- balcinrenone/dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2024to 28 Oct 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age
- Participant aged 18 to 50 years.
- Type of Participant and Disease Characteristics
- Chinese participants who are healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- Weight
- Body weight within 50.0-100.0 kg and BMI within the range 19.0-28.0 kg/m2 (inclusive) at screening.
Who cannot join
- Medical Conditions
- History of any clinically significant disease or disorder which, in the opinion of the investigator, 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 significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of IMP.
- Any clinically significant abnormal findings in vital signs, as judged by the investigator.
- Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator.
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- Any positive result on screening for serum HBsAg or anti-hepatitis B core antibody, hepatitis C antibody, and HIV antibody.
- Positive screen for drugs of abuse, alcohol or cotinine at screening or on admission to the study centre.
- Suspected or confirmed COVID-19 infection within the last 4 weeks prior to screening or admission. Or hospitalisation for COVID-19 within the last 12 weeks prior to screening or admission.
- Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
- Current smokers or those who have smoked or used nicotine products within the 3 months prior to screening.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to balcinrenone or dapagliflozin.
- Prior/Concomitant Therapy
- Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), hormone replacement therapy, herbal remedies, megadose vitamins and minerals within 14 days or 5 half-lives (whichever is longer) before the start of IMP, unless, in the opinion of the investigator, the medication will not interfere with the study.
- Prior/Concurrent another Clinical Study Experience
- Has received investigational product within 3 months (or 5 half-lives, whichever is longer) of administration of study intervention in this study.
- Other Exclusions
- Involvement in the planning and/or conduct of this study.
- Judgment by the investigator that the participant should not participate in this study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
- Previous enrolment in the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label Study to Assess the Pharmacokinetics, Safety and Tolerability Following Administration of a Single Dose of Balcinrenone/Dapagliflozin in Healthy Chinese Participants
This study is intended to evaluate the PK, safety, and tolerability of balcinrenone/dapagliflozin given as a single dose capsule to healthy Chinese participants.
Read the detailed description
This is a Phase I, open-label, single-arm, single dose PK study in healthy Chinese participants to be conducted at a single study centre in mainland China. In this study, approximately 10 participants (both females and males) will be assigned to the IMP. Each participant will receive a single dose of a capsule with balcinrenone/dapagliflozin 40 mg/10 mg on Day 1 under fasted condition. The study will comprise of the following:
- A screening period
- A treatment period
- A follow-up visit At the discretion of the investigator, the participant may remain in the study center until the completion of the follow-up visit
- Conditions
- Healthy Volunteer
- Being tested
- balcinrenone/dapagliflozin
- Keywords
- Chinese Healthy Volunteer, Phase 1, Pharmacokinetics, Safety, Tolerability, balcinrenone/dapagliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balcinrenone/dapagliflozinDrug
Each participant will receive a single dose of balcinrenone/dapagliflozin 40 mg/10 mg capsule on Day 1 under fasted condition.
Each participant will be involved in the study for up to 35 days.
| Study group | Role | What they receive |
|---|---|---|
| balcinrenone/dapagliflozin | Experimental | To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants Receives: Drug: balcinrenone/dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf of AUCinf of balcinrenone/dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Measured: Day 1 to post dose 48 hours
AUClast of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Measured: Day 1 to post dose 48 hours
Cmax of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Measured: Day 1 to post dose 48 hours
C24h of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Measured: Day 1 to post dose 48 hours
tmax of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Measured: Day 1 to post dose 48 hours
t½λz of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Measured: Day 1 to post dose 48 hours
λz of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Measured: Day 1 to post dose 48 hours
CL/F of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Measured: Day 1 to post dose 48 hours
MRTinf of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Measured: Day 1 to post dose 48 hours
Vz/F of balcinrenone /dapagliflozin
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Measured: Day 1 to post dose 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start21 Oct 2024
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651021
- Sponsor's protocol ID
- D6402C00014
- Status last verified
- Jan 2025
- First submitted
- 25 Sep 2024
- Last updated
- 15 Jan 2025
- Results posted
- 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. All request 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 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Study to Assess the Pharmacokinetics, Safety and Tolerability Following Administration of a Single Dose of Balcinrenone/Dapagliflozin in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT06651021
- Acronym / sponsor ID
- D6402C00014
- Conditions
- Healthy Volunteer
- Keywords
- Chinese Healthy Volunteer, Phase 1, Pharmacokinetics, Safety, Tolerability, balcinrenone/dapagliflozin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 21 Oct 2024 (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.
This study is intended to evaluate the PK, safety, and tolerability of balcinrenone/dapagliflozin given as a single dose capsule to healthy Chinese participants.
Detailed description
This is a Phase I, open-label, single-arm, single dose PK study in healthy Chinese participants to be conducted at a single study centre in mainland China. In this study, approximately 10 participants (both females and males) will be assigned to the IMP. Each participant will receive a single dose of a capsule with balcinrenone/dapagliflozin 40 mg/10 mg on Day 1 under fasted condition. The study will comprise of the following:
- A screening period
- A treatment period
- A follow-up visit At the discretion of the investigator, the participant may remain in the study center until the completion of the follow-up visit
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| balcinrenone/dapagliflozin | Experimental | Drug: balcinrenone/dapagliflozinTo evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age
- Participant aged 18 to 50 years.
- Type of Participant and Disease Characteristics
- Chinese participants who are healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- Weight
Key exclusion criteria (20 listed)
- Medical Conditions
- History of any clinically significant disease or disorder which, in the opinion of the investigator, 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 significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of IMP.
- Any clinically significant abnormal findings in vital signs, as judged by the investigator.
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/dapagliflozinEach participant will receive a single dose of balcinrenone/dapagliflozin 40 mg/10 mg capsule on Day 1 under fasted condition. Each participant will be involved in the study for up to 35 days. | Drug | balcinrenone/dapagliflozin |
Primary outcome
AUCinf of AUCinf of balcinrenone/dapagliflozin
Time frame: Day 1 to post dose 48 hours
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
AUClast of balcinrenone /dapagliflozin
Time frame: Day 1 to post dose 48 hours
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Cmax of balcinrenone /dapagliflozin
Time frame: Day 1 to post dose 48 hours
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
C24h of balcinrenone /dapagliflozin
Time frame: Day 1 to post dose 48 hours
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
tmax of balcinrenone /dapagliflozin
Time frame: Day 1 to post dose 48 hours
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
t½λz of balcinrenone /dapagliflozin
Time frame: Day 1 to post dose 48 hours
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
λz of balcinrenone /dapagliflozin
Time frame: Day 1 to post dose 48 hours
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
CL/F of balcinrenone /dapagliflozin
Time frame: Day 1 to post dose 48 hours
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
MRTinf of balcinrenone /dapagliflozin
Time frame: Day 1 to post dose 48 hours
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
Vz/F of balcinrenone /dapagliflozin
Time frame: Day 1 to post dose 48 hours
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
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 15 Jan 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. All request 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 in people with Healthy Volunteer, run by AstraZeneca at 1 site in China.
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 6 inclusion and 20 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 15 Jan 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 China. 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?
AUCinf of AUCinf of balcinrenone/dapagliflozin (time frame: Day 1 to post dose 48 hours). The study lists 10 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 15 Jan 2025.