Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal 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
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
Treatments tested in this trial
- AZD1613 - Part A
- Placebo - Part A
- AZD1613 - Part B
- Placebo - Part B
Treatment groups
40 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov