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

Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235375
• Other study ID #: D5670C00008
• Status: Completed
• Phase: Phase 1
• Start date: October 27, 2017
• Est. completion date: April 24, 2018

Study information

• Verified date: April 2018
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 24, 2018
• Est. primary completion date: April 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• MEDI0382
MEDI0382 administered subcutaneously

Locations

Country	Name	City	State
Germany	Research Site	Kiel
Germany	Research Site	München
New Zealand	Research Site	Auckland
New Zealand	Research Site	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

Germany,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Concentration of MEDI0382 (Cmax)	The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data	0-48 hours
Primary	Area under the Concentration Time Curve (AUC) of MEDI0382	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	0-48 hours
Secondary	Time to maximum observed concentration (Tmax)	Time to maximum observed concentration.	0-48 hours
Secondary	apparent clearance (Cl/F)	The apparent clearance will be calculated as CL/F=Dose/AUC(0-inf)	0-48 hours
Secondary	AUCinf	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.	0-48 hours
Secondary	Half-life (T1/2)	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	0-48 hours
Secondary	Anti-drug Antibody (ADA) titer	ADA titer through to day 28	Day -1 to day 28
Secondary	Number of subjects with Adverse Events	Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)	Study onset till 28 days post dosing
Secondary	Number of subjects with Adverse Events	Vital Signs (systolic and diastolic blood pressure, pulse rate, temperature and respiratory rates)	Study onset till 28 days post dosing
Secondary	Number of subjects with Adverse Events	Clinical laboratory assessments (serum chemistry, hematology, and urinalysis)	Study onset till 28 days post dosing