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NCT07024823

A Study to Investigate Safety, Tolerability, PK, and PD of AZD4248 in Healthy Participants, Participants With CKD and Type 2 Diabetes, Assess Home Measurements of Creatinine in a Non-Interventional Cohort, and Assess the Effect of AZD4248 on the PK of Midazolam and Metformin in Healthy Participants

StatusRecruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved 35 days later, primary endpoint(s) modified.

See at-risk trials from AstraZeneca

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Record History

All 14 versions: 10 with changes below, 4 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 124 → 192 participants Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Eligibility criteria expanded, about 40 words
    • Primary and study completion pushed from Dec 25, 2026 to Jan 29, 2027
    • Interventions modified
    • Trial arms changed: 7 → 8
    • Secondary endpoints: 31 to 32
    • Study description expanded, about 44 words
    • Study title expanded, about 10 words
  2. Primary and study completion pushed from Jun 18, 2026 to Dec 25, 2026
    • Eligibility criteria revised
    • Site details revised at 1 of 5 sites
    v12
  3. Primary and study completion dates: Apr 30, 2026 to Jun 18, 2026v10
  4. Enrollment target: 164 to 124v7
  5. Secondary endpoints: details revised at 1 of 31 entriesv6
Show 4 earlier versionsHide 4 earlier versions
  1. Site details revised at 4 of 5 sitesv5
  2. Primary endpoints revised (2)
    • Secondary endpoints revised (31)
    v4
  3. Study sites: 2 to 5v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Primary and study completion dates: May 1, 2026 to Apr 30, 2026
    • Start date changed from estimate of Jun 10, 2025 to Jun 9, 2025
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Parts A, B, and C: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From Day 1 to Follow Up visit (Part A: up to 12 days; Part B and C: up to 19 days)
Part D: Intra- and inter-participant variability of estimated glomerular filtration rate (eGFR) derived from home self-testing device measurements
Timeframe: Day 1 to Day 169
Part E: Area under concentration-time curve from time 0 to infinity (AUCinf) for midazolam
Timeframe: Days 1-2, 4-5, 17 and 18
Part E: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) for midazolam
Timeframe: Days 1-2, 4-5, 17 and 18
Part E: Maximum observed drug concentration (Cmax) for midazolam
Timeframe: Days 1-2, 4-5, 17 and 18
Part E: Ratio of Test treatment (AZD4248 + midazolam) to Reference (AZD4248) based on AUCinf (RAUCinf) of AZD4248
Timeframe: Days 1-2, 4-5, 17 and 18
Part E: Ratio of Test treatment (AZD4248 + midazolam) to Reference (AZD4248) based on AUClast (RAUClast) of AZD4248
Timeframe: Days 1-2, 4-5, 17 and 18
Part E: Ratio of Test treatment (AZD4248 + midazolam) to Reference (AZD4248) based on Cmax (RCmax) of AZD4248
Timeframe: Days 1-2, 4-5, 17 and 18
Part E: Terminal elimination half-life (t½λz) for midazolam
Timeframe: Days 1-2, 4-5, 17 and 18
Part E: Terminal rate constant (λz) for midazolam
Timeframe: Days 1-2, 4-5, 17 and 18
Part E: Time to reach maximum observed concentration (tmax) for midazolam
Timeframe: Days 1-2, 4-5, 17 and 18
Part E: AUCinf for metformin
Timeframe: Days 2-4, 6, and 7-16
Part E: AUClast for metformin
Timeframe: Days 2-4, 6, and 7-16
Part E: Cmax for metformin
Timeframe: Days 2-4, 6, and 7-16
Part E: Ratio of Test treatment (AZD4248 + metformin) to Reference (AZD4248) based on AUCinf (RAUCinf) of AZD4248
Timeframe: Days 2-4, 6, and 7-16
Part E: Ratio of Test treatment (AZD4248 + metformin) to Reference (AZD4248) based on AUClast (RAUClast) of AZD4248
Timeframe: Days 2-4, 6, and 7-16
Part E: Ratio of Test treatment (AZD4248 + metformin) to Reference (AZD4248) based on Cmax (RCmax) of AZD4248
Timeframe: Days 2-4, 6, and 7-16
Part E: Renal clearance (CLR) for metformin
Timeframe: Days 2-4, and 6-8
Part E: t½λz for metformin
Timeframe: Days 2-4, 6, and 7-16
Part E: λz for metformin
Timeframe: Days 2-4, 6, and 7-16
Part E: tmax for metformin
Timeframe: Days 2-4, 6, and 7-16

Secondary (32)

Area under concentration-time curve from time 0 to infinity (AUCinf)
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Dose normalized AUClast (AUClast/D)
Dose normalized AUCinf (AUCinf/D)
Apparent total body clearance (CL/F)
Show 27 moreShow less
Maximum observed drug concentration (Cmax)
Dose normalized Cmax (Cmax/D)
Terminal elimination half-life (t½λz)
Terminal rate constant (λz)
Time delay between drug administration and the first observed concentration (tlag)
Time of last quantifiable concentration (tlast)
Time to reach maximum observed concentration (tmax)
Apparent volume of distribution based on the terminal phase (Vz/F)
Absolute bioavailability (F)
Total body clearance (CL)
Volume of distribution at steady state (Vss)
Area under concentration-time curve in the dose interval (AUCtau)
Dose normalized AUCtau (AUCtau/D)
Accumulation ratio for AUC (Rac AUC)
Accumulation ratio for Cmax (Rac Cmax)
Temporal change parameter (TCP)
Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)]
Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 [fe(t1-t2)]
Renal clearance (CLR)
Percentage change from baseline in plasma target engagement marker
Part D: Intra- and inter-participant variability of eGFR derived from laboratory measurements
Part D: Changes over longitudinal follow-up in participant-reported experience questionnaire on collective participant satisfaction, usability and device acceptability data
Part D: Summary of qualitative insights from optional individual in-depth interview samples
Part D: Changes over longitudinal follow-up in site-based staff reported PTSFQ
Part D: Estimated glomerular filtration rate (eGFR)
Part D: Proportion of completed creatinine tests, with completed assessments
Part E: Number of AEs and SAEs

Arms and interventions

Part A1 SADExperimental

Participants will receive single ascending oral dose of AZD4248 or placebo.

Part A2 SAD Chinese CohortExperimental

Participants will receive single oral dose of AZD4248 or placebo.

Part A3 SAD IV CohortExperimental

Participants will receive single IV infusion of AZD4248 or placebo.

Part B1 MADExperimental

Participants will receive multiple ascending oral doses of AZD4248 or placebo.

Part B2 MAD JapaneseExperimental

Participants will receive multiple ascending oral doses of AZD4248 or placebo.

Part C Multiple Dosing DKDExperimental

Participants will receive multiple oral doses of AZD4248 or placebo.

Part D Observational CohortNo intervention

Participants will participate in home-based creatinine self-measurement.

Part E Drug-Drug Interaction CohortExperimental

Participants will receive a single dose of midazolam and metformin followed by multiple oral doses of AZD4248 with a single dose of midazolam and metformin.

Drugs: AZD4248, Placebo, Midazolam, Metformin

Sites

5 sites in 1 country