Health Trials

Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease

ConditionAutosomal Dominant Polycystic Kidney Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAstraZeneca

About this trial

A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with ADPKD Mayo Class (IB-IE), as per clinical diagnosis (MIC) assessed centrally. Genetic testing results will not be used for eligibility purposes

eGFR = 45 to 90 mL/min /1.73m2

Body weight ≥ 45 kg and body mass index within the range 18 to 35 kg/m2 (inclusive).

Females are to be of non-childbearing potential

Disqualifiers

As judged by the investigator, any evidence of cardiac, vascular, and other renal conditions which in the investigator's opinion makes it undesirable for the participant to participate in the study.

Positive hepatitis C antibody, hepatitis B virus surface antigen, or human immunodeficiency virus test, at screening.

History of QT prolongation associated with other medications that required discontinuation of that medication.

Congenital long QT syndrome.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AZD1613 - Part A

    Drug

    Part A - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.

  • Placebo - Part A

    Drug

    Part A - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.

  • AZD1613 - Part B

    Drug

    Part B - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.

  • Placebo - Part B

    Drug

    Part B - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Part A - Cohort A1Experimental treatment 2 interventions
Group B: Part A - Cohort A2Experimental treatment 2 interventions
Group C: Part B - Chinese CohortExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Number of participants with at least one TEAE and SAE, including events leading to discontinuation or death; coded by system organ class and preferred term. Unit: participants.

Time frame
From randomization (Day 1) through end of follow-up (up to Day 189 ±3 days)
2

Change From Baseline in Safety 12-Lead ECG QTcF

Change from baseline in QT interval corrected using Fridericia's formula (QTcF) measured on single 12-lead safety ECGs. Unit: milliseconds (ms).

Time frame
Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
3

Change From Baseline in Safety 12-Lead ECG PR Interval

Change from baseline in PR interval measured on single 12-lead safety ECGs. Unit: milliseconds (ms).

Time frame
Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
4

Change From Baseline in Safety 12-Lead ECG QRS Duration

Change from baseline in QRS duration measured on single 12-lead safety ECGs. Unit: milliseconds (ms).

Time frame
Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days

Secondary outcomes

1

Maximum Observed Serum Concentration (Cmax) of AZD1613

Maximum observed serum concentration following subcutaneous or intravenous administration. Unit: µg/mL.

Time frame
Intensive PK sampling from Day 1 through Day 189 per protocol schedule
2

Area Under the Concentration-Time Curve to Last Quantifiable Concentration (AUClast) of AZD1613

AUC from time zero to last quantifiable concentration. Unit: h·µg/mL (or day·µg/mL; align with bioanalytical report).

Time frame
Intensive PK sampling from Day 1 through Day 189 per protocol schedule
3

Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of AZD1613

AUC from time zero extrapolated to infinity. Unit: h·µg/mL (or day·µg/mL).

Time frame
Intensive PK sampling from Day 1 through Day 189 per protocol schedule
4

Area Under the Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau) of AZD1613

AUC over the dosing interval at steady state. Unit: h·µg/mL (or day·µg/mL).

Time frame
Over the dosing interval (τ = 28 days) at steady state; sampling through Day 189

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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