Study to Assess the Pharmacokinetics and Safety of AZD9977 in Participants With Renal Impairment

• Status: Recruiting
• Trial end date: 2021-12-15
• Target enrollment: 0
• Participant gender: All

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 renal function. The duration of the study for an individual participant from Screening to Follow-up will be approximately 5 weeks.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria:

Healthy matched control participants only (Cohort 4):

1. Participants who are overtly healthy.

2. Stable renal function, with eGFR of ≥ 90 mL/min/1.73m^2.

Renally impaired participants only (Cohorts 1-3):

3. Participants who have renal impairment:

1. Cohort 1 participants with severe renal impairment must have an eGFR lesser than 30 mL/min/1.73m^2 not on dialysis

2. 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

3. 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):

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.

5. Male or female of non-childbearing potential.

6. Male participants should not donate sperm for the duration of the study.

7. Female participants must have a negative pregnancy test at time of study entry.

8. Capable of giving signed informed consent.

Exclusion Criteria:

Healthy matched control participants only (Cohort 4):

1. Evidence of clinically significant cardiovascular, hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, neurologic, psychiatric, inflammatory or allergic disease.

Renally impaired participants only (Cohorts 1-3):

2. Renal transplant participants, participants on dialysis and those with a history of acute kidney injury.

All participants (Cohorts 1-4):

3. Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus antibody.

4. Known history of drug or alcohol abuse.

5. History of QT prolongation and arrhythmia.

6. Any moderate or potent inhibitors or inducers of CYP3A4.

7. Participants with a known hypersensitivity to AZD9977 or any of the excipients of the product.

8. For women only - currently pregnant or breast-feeding.

9. 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.