Clinical trial NCT06651021: A Phase I PK Study of Balcinrenone/Dapagliflozin in Healthy Chinese Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Chinese Healthy Volunteer
Phase 1
Pharmacokinetics
Safety
Tolerability
balcinrenone/dapagliflozin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-10-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

Age

1. Participant aged 18 to 50 years.

   Type of Participant and Disease Characteristics
2. Chinese participants who are healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.

   Weight
3. Body weight within 50.0-100.0 kg and BMI within the range 19.0-28.0 kg/m2 (inclusive) at screening.

Exclusion Criteria:

Medical Conditions

1. 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.
2. History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
3. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of IMP.
4. Any clinically significant abnormal findings in vital signs, as judged by the investigator.
5. Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator.
6. Any positive result on screening for serum HBsAg or anti-hepatitis B core antibody, hepatitis C antibody, and HIV antibody.
7. Positive screen for drugs of abuse, alcohol or cotinine at screening or on admission to the study centre.
8. 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.
9. Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
10. Current smokers or those who have smoked or used nicotine products within the 3 months prior to screening.
11. 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
12. 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
13. Has received investigational product within 3 months (or 5 half-lives, whichever is longer) of administration of study intervention in this study.

    Other Exclusions
14. Involvement in the planning and/or conduct of this study.
15. 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.
16. Previous enrolment in the present study.

Primary outcomes:
measure: AUCinf of AUCinf of balcinrenone/dapagliflozin
timeFrame: Day 1 to post dose 48 hours
measure: AUClast of balcinrenone /dapagliflozin
timeFrame: Day 1 to post dose 48 hours
measure: Cmax of balcinrenone /dapagliflozin
timeFrame: Day 1 to post dose 48 hours
measure: C24h of balcinrenone /dapagliflozin
timeFrame: Day 1 to post dose 48 hours
measure: tmax of balcinrenone /dapagliflozin
timeFrame: Day 1 to post dose 48 hours
measure: t½λz of balcinrenone /dapagliflozin
timeFrame: Day 1 to post dose 48 hours
measure: λz of balcinrenone /dapagliflozin
timeFrame: Day 1 to post dose 48 hours
measure: CL/F of balcinrenone /dapagliflozin
timeFrame: Day 1 to post dose 48 hours
measure: MRTinf of balcinrenone /dapagliflozin
timeFrame: Day 1 to post dose 48 hours
measure: Vz/F of balcinrenone /dapagliflozin
timeFrame: Day 1 to post dose 48 hours
Secondary outcomes:
Other outcomes:
measure: Incidence of AEs and SAEs
timeFrame: From ICF throughout the treatment period and including the follow-up period (7 days post-dose）
measure: Incidence of abnormal Supine blood pressure
timeFrame: From ICF throughout the treatment period and including the follow-up period (7 days post-dose）
measure: Incidence of abnormal Supine Pulse
timeFrame: From ICF throughout the treatment period and including the follow-up period (7 days post-dose）
measure: Height in centimeter
timeFrame: From ICF throughout the treatment period and including the follow-up period (7 days post-dose）
measure: Weight in Kilograms
timeFrame: From ICF throughout the treatment period and including the follow-up period (7 days post-dose）
measure: Incidence of abnormal clinical chemistry assessments：Glucose, HbA1c, Creatinine, , ALP, ALP, ALT, AST, total bilirubin, Potassium, Chloride, Bicarbonate, Calcium (total), magnesium, Phosphorous, Sodium, CK, eGFR, FSH, hCG
timeFrame: From ICF throughout the treatment period and including the follow-up period (7 days post-dose）
measure: Incidence of abnormal urinalysis: Glucose, Haemoglobin, Protein/Albumin, hCG
timeFrame: From ICF throughout the treatment period and including the follow-up period (7 days post-dose）
measure: Incidence of abnormal haematology assessments: Haematocrit, Hb, Platelet count, RBC, WBC
timeFrame: From ICF throughout the treatment period and including the follow-up period (7 days post-dose）
measure: Incidence of abnormal of Electrocardiogram parameter: ECG mean heart rate
timeFrame: From ICF throughout the treatment period and including the follow-up period (7 days post-dose）
measure: Incidence of abnormal of Electrocardiogram parameter: ECG Heart rhythm
timeFrame: From ICF throughout the treatment period and including the follow-up period (7 days post-dose）
measure: Incidence of abnormal of Electrocardiogram parameter: ECG QRS duration, QT interval, QTc interval Fridericia
timeFrame: From ICF throughout the treatment period and including the follow-up period (7 days post-dose）
measure: Incidence of abnormal physical examination: assessments of general appearance, respiratory, CV, abdomen, neurological systems, the skin, lymph nodes
timeFrame: From ICF throughout the treatment period and including the follow-up period (7 days post-dose）
measure: Incidence of abnormal physical examination: assessment of the presence and extent of peripheral (ankle/leg) oedema
timeFrame: From ICF throughout the treatment period and including the follow-up period (7 days post-dose）
Locations:
city: Chengdu
country: China
facility: Research Site
Study officials:
References: