DRUG
MEDI0382
MEDI0382 administered subcutaneously
A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects
Status
Completed
Phase
Phase 1
Enrollment
37
Locations
4
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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 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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Aug 1, 2017
Study start
Oct 27, 2017
Primary completion
Apr 24, 2018
Study completion
Apr 24, 2018
Results posted
Not reported
Registry updated
May 1, 2018
Outcomes
What the study measures.
Primary outcomes
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 outcomes
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)
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 85 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
4 registered sites.
Germany · New Zealand. Showing up to 24 locations stored in the fast local snapshot.
Research Site
Kiel, Germany
Research Site
München, Germany
Research Site
Auckland, New Zealand
Research Site
Christchurch, New Zealand
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