A Phase I PK Study of Balcinrenone/Dapagliflozin in Healthy Chinese Participants

NCT06651021 | Completed Phase 1

• 1 other identifier: D6402C00014
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Keywords

Chinese Healthy Volunteer; Phase 1; Pharmacokinetics; Safety; Tolerability; balcinrenone/dapagliflozin

Outcome Measures

Primary Outcomes (10)

• AUCinf of AUCinf of balcinrenone/dapagliflozin

  To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants

  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

  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

  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

  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

  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

  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

  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

  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

  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

  Day 1 to post dose 48 hours

Other Outcomes (13)

• Incidence of AEs and SAEs

  From ICF throughout the treatment period and including the follow-up period (7 days post-dose）

• Incidence of abnormal Supine blood pressure

  From ICF throughout the treatment period and including the follow-up period (7 days post-dose）

• Incidence of abnormal Supine Pulse

  From ICF throughout the treatment period and including the follow-up period (7 days post-dose）

Study Arms (1)

balcinrenone/dapagliflozin

EXPERIMENTAL

To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants

Drug: balcinrenone/dapagliflozin

Interventions

balcinrenone/dapagliflozin DRUG

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.

balcinrenone/dapagliflozin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Chengdu, 610041, China

Location

MeSH Terms

Interventions

dapagliflozin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 21, 2024
• Study Start: October 21, 2024
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma 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 deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

CN (1)