A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects

A Phase 1, Open-Label, Single Dose, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of MEDI0382 in Subjects With Renal Impairment

A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of MEDI0382 in subjects with renal impairment.

This is an open-label, single-dose, parallel group study to evaluate the PK, safety, tolerability, and immunogenicity of MEDI0382 in subjects with renal impairment. Enrollment of approximately 40 subjects across multiple sites is planned. Subjects will be divided into 4 groups based on renal function.

Inclusion Criteria:

• Must provide written informed consent
• BMI greater than or equal to 17 and less than or equal to 40 kg/m2
• Creatinine clearance rate greater than or equal to 90 (healthy); or renally impaired (less than 60 mL/min)
• Females of childbearing potential must use a highly effective form of contraception.

Exclusion Criteria:

• Any history of or concurrent condition that in the opinion of the investigator would compromise the subjects safety.
• Subjects on dialysis
• Subjects with pancreatitis
• Renal transplant subjects
• Females pregnant or lactating