Study of the Effect of Haemodialysis on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone/Dapagliflozin

NCT07754331 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: D8790C00002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of HD on single oral dose PK, safety, and tolerability of balcinrenone/dapagliflozin to male and female participants with kidney failure on intermittent HD.

Conditions

Kidney Failure

Outcome Measures

Primary Outcomes (14)

• PK parameters AUCinf

  To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin

  Day 1 to 3 for each treatment period (each treatment period is 4 days)

• PK Parameters AUClast

  To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin

  Day 1 to 3 for each treatment period (each treatment period is 4 days)

• PK Parameters Cmax

  To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin

  Day 1 to 3 for each treatment period (each treatment period is 4 days)

• PK parameters C24 from plasma

  To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD

  Day 1 to 3 for each treatment period (each treatment period is 4 days)

• PK parameters tmax from plasma

  To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD

  Day 1 to 3 for each treatment period (each treatment period is 4 days)

• PK parameters t1/2λz from plasma

  To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD

  Day 1 to 3 for each treatment period (each treatment period is 4 days)

• PK parameters CLNR (balcinrenone only) from plasma

  To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD

  Day 1 to 3 for each treatment period (each treatment period is 4 days)

• PK parameters CL/F from plasma

  To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD

  Day 1 to 3 for each treatment period (each treatment period is 4 days)

• PK parameters AUC(t1-t2)_out from plasma

  To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD

  Day 1 to 3 for each treatment period (each treatment period is 4 days)

• PK parameters CLD from dialysate

  To evaluate the PK of balcinrenone/dapagliflozin in dialysate in participants with kidney failure on HD

  Day 1 to 3 for each treatment period (each treatment period is 4 days)

• PK parameters AeD from dialysate

  To evaluate the PK of balcinrenone/dapagliflozin in dialysate in participants with kidney failure on HD

  Day 1 to 3 for each treatment period (each treatment period is 4 days)

• PK parameters feD from dialysate

  To evaluate the PK of balcinrenone/dapagliflozin in dialysate in participants with kidney failure on HD

  Day 1 to 3 for each treatment period (each treatment period is 4 days)

• PK parameters Vz/F from plasma

  To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD

  Day 1 to 3 for each treatment period (each treatment period is 4 days)

• PK parameters AUC(t1-t2) from plasma

  To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD

  Day 1 to 3 for each treatment period (each treatment period is 4 days)

Secondary Outcomes (2)

• AEs

  from Period 1, Day 1 until follow-up on Day 9-11 post-dose Period 2.

• SAEs

  from screening until follow-up on Day 9-11 post-dose Period 2

Study Arms (2)

Sequence AB

OTHER

Two hours after completion of a breakfast meal on Day 1, a single oral balcinrenone/dapagliflozin dose will be administered. A 4-hour HD session will start 1.5 hours after dose administration.

Drug: Balcinrenone/dapagliflozin

Sequence BA

OTHER

One hour after completion of a breakfast meal on Day 1, a 4-hour HD session will start. One hour after completion of the HD session a single oral balcinrenone/dapagliflozin dose will be administered.

Drug: Balcinrenone/dapagliflozin

Interventions

Balcinrenone/dapagliflozin DRUG

40 mg/10 mg balcinrenone/dapagliflozin (capsule)

Sequence AB; Sequence BA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must have kidney failure and must have been on stable intermittent HD for at least 3 months prior to screening.
• Participant must be stable on a concomitant medication and/or treatment regimen (defined as not starting a new treatment/medication\[s\] or a change in the dosage or frequency of the concomitant medication\[s\] within at least 4 weeks prior to screening).
• Participants with controlled T2DM may be included, if they have: (a) HbA1c ≤ 10% at screening.
• Body weight ≥ 50 kg and BMI within the range 18 to 40 kg/m2, inclusive, as measured at screening.
• All female participants must have a negative serum pregnancy test at screening and all females of child-bearing potential must have a negative serum pregnancy test on Periods 1 and 2 Day -1 and must not be lactating (confirmed at screening). Females must also fulfil one of the following criteria: Females not of child-bearing potential, defined as females who are either permanently sterilised (hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation) or who are post-menopausal; OR Females of child-bearing potential who are sexually active with a nonsterilised male must use one highly effective method of birth control from enrolment throughout the study and until at least 4 weeks after the last dose of study intervention
• Capable of giving signed informed consent
• Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form prior to collection of samples for optional genomics initiative research that supports the Genomic Initiative

You may not qualify if:

• Presence of any uncontrolled or clinically significant disease or disorder (other than renal disease and conditions related to the renal disease, such as stable T2DM and stable hypertension), or any medical or surgical condition that, in the opinion of the investigator, may either interfere with participation in the clinical study and/or put the participant at significant risk (according to the investigator's judgement) if he/she participates in the clinical study.
• Any clinically significant illness, medical/major surgical procedure, or trauma within 4 weeks prior to the first study intervention
• Severe hepatic impairment (CP Class C).
• 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 and dapagliflozin
• Abnormal resting vital signs at screening or Period 1 Day -1 (after resting for at least 5 minutes) of: (a) supine BP: (i) \> 180 mmHg or \< 90 mmHg systolic. (ii) \> 95 mmHg or \< 40 mmHg diastolic.
• Successful renal transplant patients, participants waiting for organ transplant scheduled to occur during the study, and those with a history of acute kidney injury occurring within 3 months prior to screening. Nonfunctioning renal allografts are allowed
• Any clinically significant abnormalities on 12-lead ECG at the screening, as judged by the investigator
• Positive test for human immunodeficiency virus at screening.
• Positive results at screening for hepatitis B surface antigen or hepatitis C antibody.
• Known history of drug or alcohol abuse within 1 year of screening and/or consumes \> 14 units per week for males and \> 7 units per week for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine
• The following medications are prohibited within 4 weeks prior to the first study intervention until follow-up: (a) MR antagonists; (b) SGLT2 inhibitors
• The following medications are prohibited within 1 week prior to the first study intervention until follow-up: Strong or moderate inducers or inhibitors of CYP3A4
• Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days prior to study intervention in this study or, if known, 5 half-lives from last dose in the previous study to study intervention in this study, whichever is longest
• Previous enrolment in the present study.
• Positive screen for drugs of abuse including cannabis/marijuana and/or alcohol test at screening or Period 1 Day -1.

Sponsors & Collaborators

• AstraZeneca: lead
• Fortrea: collaborator

Study Sites (1)

Research Site

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

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

Model Details: There will be two treatment periods performed in a crossover fashion in order to evaluate the PK of 40 mg/10 mg balcinrenone/dapagliflozin with dosing before and after HD, with a 7-day washout period between the two treatments.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: August 10, 2026
• Study Start: August 5, 2026
• Primary Completion (Estimated): December 2, 2026
• Study Completion (Estimated): December 2, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

US (1)