Safety, tolerability and pharmacokinetics of AZD1613 in adults with autosomal dominant polycystic kidney disease - PIONEER-PKD

Inclusion Criteria

• 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.