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

• Status: Completed
• Trial end date: 2018-04-24
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC

Criteria

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