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

MedImmune

Status and phase: Completed; Phase 1

Conditions: Renal Insufficiency

Treatments: Drug: MEDI0382

Study type: Interventional

Funder types: Industry

Identifiers

NCT03235375

D5670C00008

Details and patient eligibility

About

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

Full description

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 4 patient groups

Group 1: End Stage Renal Disease (ESRD)

Experimental group

Description:

Subjects with CrCl \<20ml/min will receive MEDI0382 administered subcutaneously

Treatment:

Drug: MEDI0382

Group 2: Severe and ESRD Subjects

Experimental group

Description:

Subjects with CrCl \>20 and \< 30 ml/min will receive MEDI0382 administered subcutaneously

Treatment:

Drug: MEDI0382

Group 3: Healthy Subjects

Active Comparator group

Description:

Subjects with CrCl \>90 ml/min will receive MEDI0382 administered subcutaneously

Treatment:

Drug: MEDI0382

Group 4: Moderate Renal Disease

Experimental group

Description:

Subjects with CrCl \> or equal to 30 and \< 60 mL/min will receive MEDI0382 administered subcutaneously

Treatment:

Drug: MEDI0382