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

Sponsor

MedImmune LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT03235375

Collaborator

(none)

Enrollment

Locations

Arms

5.9

Actual Duration (Months)

9.3

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency	Drug: MEDI0382	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Oct 27, 2017

Actual Primary Completion Date :

Apr 24, 2018

Actual Study Completion Date :

Apr 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: End Stage Renal Disease (ESRD) Subjects with CrCl <20ml/min will receive MEDI0382 administered subcutaneously	Drug: MEDI0382 MEDI0382 administered subcutaneously
Experimental: Group 2: Severe and ESRD Subjects Subjects with CrCl >20 and < 30 ml/min will receive MEDI0382 administered subcutaneously	Drug: MEDI0382 MEDI0382 administered subcutaneously
Active Comparator: Group 3: Healthy Subjects Subjects with CrCl >90 ml/min will receive MEDI0382 administered subcutaneously	Drug: MEDI0382 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	Drug: MEDI0382 MEDI0382 administered subcutaneously

Outcome Measures

Primary Outcome Measures

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

Time to maximum observed concentration (Tmax) [0-48 hours]
Time to maximum observed concentration.
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
Anti-drug Antibody (ADA) titer [Day -1 to day 28]
ADA titer through to day 28
Number of subjects with Adverse Events [Study onset till 28 days post dosing]
Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)
Number of subjects with Adverse Events [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 [Study onset till 28 days post dosing]
Clinical laboratory assessments (serum chemistry, hematology, and urinalysis)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Research Site	Kiel	Germany	24105
2	Research Site	München	Germany	81241
3	Research Site	Auckland	New Zealand	1010
4	Research Site	Christchurch	New Zealand	8011

Sponsors and Collaborators

MedImmune LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

MedImmune LLC

ClinicalTrials.gov Identifier:

NCT03235375

Other Study ID Numbers:

D5670C00008

First Posted:

Aug 1, 2017

Last Update Posted:

May 1, 2018

Last Verified:

Apr 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by MedImmune LLC

Kidney Failure, Kidney Insufficiency, Renal Failure, Renal Insufficiency, MEDI0382

Additional relevant MeSH terms:

Renal Insufficiency

Study Results

No Results Posted as of May 1, 2018