A Phase 1, Open-Label, Single Dose, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of MEDI0382 in Subjects With Renal Impairment
Overview
- Phase
- Phase 1
- Intervention
- MEDI0382
- Conditions
- Renal Insufficiency
- Sponsor
- MedImmune LLC
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Maximum Observed Concentration of MEDI0382 (Cmax)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility 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
Arms & Interventions
Group 1: End Stage Renal Disease (ESRD)
Subjects with CrCl \<20ml/min will receive MEDI0382 administered subcutaneously
Intervention: MEDI0382
Group 2: Severe and ESRD Subjects
Subjects with CrCl \>20 and \< 30 ml/min will receive MEDI0382 administered subcutaneously
Intervention: MEDI0382
Group 3: Healthy Subjects
Subjects with CrCl \>90 ml/min will receive MEDI0382 administered subcutaneously
Intervention: MEDI0382
Group 4: Moderate Renal Disease
Subjects with CrCl \> or equal to 30 and \< 60 mL/min will receive MEDI0382 administered subcutaneously
Intervention: MEDI0382
Outcomes
Primary Outcomes
Maximum Observed Concentration of MEDI0382 (Cmax)
Time Frame: 0-48 hours
The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data
Area under the Concentration Time Curve (AUC) of MEDI0382
Time Frame: 0-48 hours
The area under the plasma concentration-time curve to 48 hours concentration determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations
Secondary Outcomes
- Time to maximum observed concentration (Tmax)(0-48 hours)
- apparent clearance (Cl/F)(0-48 hours)
- AUCinf(0-48 hours)
- Half-life (T1/2)(0-48 hours)
- Anti-drug Antibody (ADA) titer(Day -1 to day 28)
- Number of subjects with Adverse Events(Study onset till 28 days post dosing)