A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects
- Registration Number
- NCT03235375
- Lead Sponsor
- MedImmune LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: End Stage Renal Disease (ESRD) MEDI0382 Subjects with CrCl \<20ml/min will receive MEDI0382 administered subcutaneously Group 2: Severe and ESRD Subjects MEDI0382 Subjects with CrCl \>20 and \< 30 ml/min will receive MEDI0382 administered subcutaneously Group 3: Healthy Subjects MEDI0382 Subjects with CrCl \>90 ml/min will receive MEDI0382 administered subcutaneously Group 4: Moderate Renal Disease MEDI0382 Subjects with CrCl \> or equal to 30 and \< 60 mL/min will receive MEDI0382 administered subcutaneously
- Primary Outcome Measures
Name Time Method Maximum Observed Concentration of MEDI0382 (Cmax) 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 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 Outcome Measures
Name Time Method Anti-drug Antibody (ADA) titer Day -1 to day 28 ADA titer through to day 28
Time to maximum observed concentration (Tmax) 0-48 hours Time to maximum observed concentration.
Number of subjects with Adverse Events Study onset till 28 days post dosing Clinical laboratory assessments (serum chemistry, hematology, and urinalysis)
apparent clearance (Cl/F) 0-48 hours The apparent clearance will be calculated as CL/F=Dose/AUC(0-inf)
AUCinf 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) 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
Trial Locations
- Locations (1)
Research Site
🇳🇿Christchurch, New Zealand