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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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. - History of ventricular arrhythmia requiring treatment. Patients with atrial fibrillation/flutter and controlled ventricular rate HR < 100 bpm can be eligible as judged by the investigator. - Haemoglobin below the lower limit of the normal range or any other clinically significant haematological abnormality as judged by the investigator. - Any clinically important abnormalities in clinical chemistry, haematology, coagulation, or urinalysis results other than those specifically described as exclusion criteria herein, as judged by the investigator. - Systolic BP > 160 mmHg or diastolic BP > 100mmHg or HR < 50 bpm or > 100 bpm at screening. Patients taking anti-hypertensive medication should be on a stable treatment regimen of antihypertensive therapy for at least 30 days prior to the screening visit. - Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, as considered by the investigator, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy. - Kidney cyst interventions such as cyst aspiration or cyst fenestration within 12 weeks prior to screening and during the screening period, or such interventions planned or anticipated within the follow-up period.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a Phase I, first-in-patient, randomized, single-blind, placebo-controlled study with a sequential MAD design in participants with autosomal dominant polycystic kidney disease (ADPKD). AZD1613 will be administered either subcutaneously or intravenously in up to 5 cohorts.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
This study will be single-blinded in order to minimize bias in the collection and evaluation of data during its conduct.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A - Cohort A1 		Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85.
  • Drug: AZD1613 - Part A
    Part A - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.
  • Drug: Placebo - Part A
    Part A - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.
Experimental
Part A - Cohort A2 		Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85.
  • Drug: AZD1613 - Part A
    Part A - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.
  • Drug: Placebo - Part A
    Part A - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.
Experimental
Part B - Chinese Cohort 		Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85.
  • Drug: AZD1613 - Part A
    Part A - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.
  • Drug: AZD1613 - Part B
    Part B - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.
  • Drug: Placebo - Part B
    Part B - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.

Recruiting Locations

Research Site
Orlando 4167147, Florida 4155751 32808

Research Site
Lenexa 4274356, Kansas 4273857 66219

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

This Phase I, randomised, single-blind, placebo-controlled study will assess the safety and tolerability of AZD1613 and characterise the pharmacokinetics (PK) of AZD1613 in participants with autosomal dominant polycystic kidney disease (ADPKD), following subcutaneous (SC) or intravenous (IV) administration. Inclusion of participants receiving placebo is appropriate for benchmarking the safety and tolerability of AZD1613. Furthermore, the safety and PK profile will be evaluated in Chinese participants with ADPKD to assess any potential race effect in this population.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.