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

Part of paid clinical trials in Orlando, Florida.

Sponsor
AstraZeneca
Study ID
NCT07754331
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Kidney Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Aug 10, 2026
Start date
Aug 6, 2026
Status verified
Sep 2026
Primary completion
Dec 3, 2026
Completion
Dec 3, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Other: Sequence AB
    Participants will receive Treatment A (balcinrenone/dapagliflozin capsule administered 1,5 hours before the start of a 4-hour hemodialysis session) on Day 1. After a wash-out period of ≥ 7 days, participants will receive Treatment B (balcinrenone/dapagliflozin capsule administered 1 hour after the completion of a 4-hour hemodialysis session)
  • Other: Sequence BA
    Participants will receive Treatment B (balcinrenone/dapagliflozin capsule administered 1 hour after the completionof a 4-hour hemodialysis session) on Day 1. After a wash-out period of ≥ 7 days, participants will receive Treatment A (balcinrenone/dapagliflozin capsule administered 1.5 hours before the start of a 4-hour hemodialysis session)

Primary Outcome Measure

PK parameters AUCinf [ Time Frame: Day 1 to 3 for each treatment period (each treatment period is 4 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteOrlandoFlorida32809-

Related Studies