Status:
COMPLETED
Study to Assess the Pharmacokinetics and Safety of AZD9977 in Participants With Renal Impairment
Lead Sponsor:
AstraZeneca
Conditions:
Renal Impairment
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This is a single dose, non-randomized, open-label, parallel group study. The study will be conducted in participants with severe renal impairment and compared with matched participants with normal ren...
Detailed Description
The study will have 4 cohorts, consisting of participants with severe renal impairment who are not on dialysis (Cohort 1), moderate renal impairment (Cohort 2), mild renal impairment (Cohort 3) and pa...
Eligibility Criteria
Inclusion
- Healthy matched control participants only (Cohort 4):
- Participants who are overtly healthy.
- Stable renal function, with eGFR of ≥ 90 mL/min/1.73m\^2.
- Renally impaired participants only (Cohorts 1-3):
- Participants who have renal impairment:
- Cohort 1 participants with severe renal impairment must have an eGFR lesser than 30 mL/min/1.73m\^2 not on dialysis
- Cohort 2 participants with moderate renal impairment must have an eGFR of greater than or equal to 30 to lesser than 60 mL/min/1.73m\^2
- Cohort 3 participants with mild renal impairment must have an eGFR of greater than or equal to 60 to lesser than 90 mL/min/1.73m\^2.
- All participants (Cohorts 1-4):
- Body weight of at least 50 kg and BMI within the range greater than or equal to 18 to lesser than or equal to 35 kg/m\^2.
- Male or female of non-childbearing potential.
- Male participants should not donate sperm for the duration of the study.
- Female participants must have a negative pregnancy test at time of study entry.
- Capable of giving signed informed consent.
Exclusion
- Healthy matched control participants only (Cohort 4):
- Evidence of clinically significant cardiovascular, hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, neurologic, psychiatric, inflammatory or allergic disease.
- Renally impaired participants only (Cohorts 1-3):
- Renal transplant participants, participants on dialysis and those with a history of acute kidney injury.
- All participants (Cohorts 1-4):
- Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus antibody.
- Known history of drug or alcohol abuse.
- History of QT prolongation and arrhythmia.
- Any moderate or potent inhibitors or inducers of CYP3A4.
- Participants with a known hypersensitivity to AZD9977 or any of the excipients of the product.
- For women only - currently pregnant or breast-feeding.
- A positive local diagnostic test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening, clinical signs and symptoms consistent with COVID-19, or the patient has been previosuly hospitalised with COVID-19 infection.
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04469907
Start Date
June 22 2020
End Date
October 28 2021
Last Update
March 11 2022
Active Locations (6)
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1
Research Site
Northridge, California, United States, 91324
2
Research Site
DeLand, Florida, United States, 32720
3
Research Site
Hialeah, Florida, United States, 33014
4
Research Site
Jacksonville, Florida, United States, 32216