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balcinrenone/ dapagliflozin

Phase 1

Healthy Participants | Small molecule | Other |AstraZeneca PLC|Last Updated: Aug 12, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06979388A 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.PHASE1 COMPLETED 14 — — May 20, 2025Jul 12, 2025Aug 12, 20251 United Kingdom
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Study Endpoints
Primary Endpoints
Area under concentration-time curve from time zero to infinity (AUCinf)
From Day 1 to Day 10
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
From Day 1 to Day 10
Maximum observed drug concentration (Cmax)
From Day 1 to Day 10
Terminal elimination half-life (t1/2λz)
From Day 1 to Day 10
Time to reach maximum observed concentration (tmax)
From Day 1 to Day 10
Apparent volume of distribution based on the terminal phase (Vz/F)
From Day 1 to Day 10
Apparent total body clearance (CL/F)
From Day 1 to Day 10
Renal Clearance (CLR) (balcinrenone only)
From Day 1 to Day 10
Drug concentration in plasma at 24 hours post-dose (C24)
From Day 1 to Day 10
Secondary Endpoints
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
From Screening (Day -28 to Day -2) until Follow-up (Day 12 to Day 14)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment ABCEXPERIMENTALParticipants 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 ACBEXPERIMENTALThe 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 BCAEXPERIMENTALThe 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 BACEXPERIMENTALThe 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 CABEXPERIMENTALThe 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 CBAEXPERIMENTALThe 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.
Interventions
NameTypeDescription
balcinrenone/ dapagliflozinDRUGParticipants will be receiving balcinrenone/ dapagliflozine in fasted or fed condition.
quinidineDRUGParticipants will be receiving quinidine orally in fasted condition.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 heteros...

Countries:United Kingdom
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