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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 24, 2018

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.

Interventions

  • Drug: MEDI0382
    • MEDI0382 administered subcutaneously

Arms, Groups and Cohorts

  • Experimental: Group 1: End Stage Renal Disease (ESRD)
    • Subjects with CrCl <20ml/min will receive MEDI0382 administered subcutaneously
  • Experimental: Group 2: Severe and ESRD Subjects
    • Subjects with CrCl >20 and < 30 ml/min will receive MEDI0382 administered subcutaneously
  • Active Comparator: Group 3: Healthy Subjects
    • Subjects with CrCl >90 ml/min will receive MEDI0382 administered subcutaneously
  • Experimental: Group 4: Moderate Renal Disease
    • Subjects with CrCl > or equal to 30 and < 60 mL/min will receive MEDI0382 administered subcutaneously

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Time to maximum observed concentration (Tmax)
    • Time Frame: 0-48 hours
    • Time to maximum observed concentration.
  • apparent clearance (Cl/F)
    • Time Frame: 0-48 hours
    • The apparent clearance will be calculated as CL/F=Dose/AUC(0-inf)
  • AUCinf
    • Time Frame: 0-48 hours
    • The AUC extrapolated to infinity will be calculated, where data permit, as the sum of AUC((0-t) and Ct/z, where Ct is the observed plasma concentration obtained from the log-linear regression analysis of the last quantifiable time-point and z is the terminal phase rate constant.
  • Half-life (T1/2)
    • Time Frame: 0-48 hours
    • The apparent terminal elimination half-life (t1/2) obtained as the ratio of ln2/z, where z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data
  • Anti-drug Antibody (ADA) titer
    • Time Frame: Day -1 to day 28
    • ADA titer through to day 28
  • Number of subjects with Adverse Events
    • Time Frame: Study onset till 28 days post dosing
    • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)
  • Number of subjects with Adverse Events
    • Time Frame: Study onset till 28 days post dosing
    • Vital Signs (systolic and diastolic blood pressure, pulse rate, temperature and respiratory rates)
  • Number of subjects with Adverse Events
    • Time Frame: Study onset till 28 days post dosing
    • Clinical laboratory assessments (serum chemistry, hematology, and urinalysis)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • MedImmune LLC
  • Provider of Information About this Clinical Study
    • Sponsor

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