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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03235375

Enrollment

Registered

2017-08-01

Start date

2017-10-27

Completion date

2018-04-24

Last updated

2018-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency

Keywords

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

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.

Interventions

DRUGMEDI0382

MEDI0382 administered subcutaneously

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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
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

Secondary

Measure	Time frame	Description
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
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	Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)
Anti-drug Antibody (ADA) titer	Day -1 to day 28	ADA titer through to day 28
apparent clearance (Cl/F)	0-48 hours	The apparent clearance will be calculated as CL/F=Dose/AUC(0-inf)

Countries

Germany, New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026