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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03235375




Registration number
NCT03235375
Ethics application status
Date submitted
27/07/2017
Date registered
1/08/2017
Date last updated
1/05/2018

Titles & IDs
Public title
A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects
Scientific 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
Secondary ID [1] 0 0
D5670C00008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Insufficiency 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MEDI0382

Experimental: Group 1: End Stage Renal Disease (ESRD) - Subjects with CrCl <20ml/min will receive MEDI0382 administered subcutaneously

Experimental: Group 2: Severe and ESRD Subjects - Subjects with CrCl >20 and < 30 ml/min will receive MEDI0382 administered subcutaneously

Active Comparator: Group 3: Healthy Subjects - Subjects with CrCl >90 ml/min will receive 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


Treatment: Drugs: MEDI0382
MEDI0382 administered subcutaneously

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Observed Concentration of MEDI0382 (Cmax) - The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data
Timepoint [1] 0 0
0-48 hours
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
0-48 hours
Secondary outcome [1] 0 0
Time to maximum observed concentration (Tmax) - Time to maximum observed concentration.
Timepoint [1] 0 0
0-48 hours
Secondary outcome [2] 0 0
apparent clearance (Cl/F) - The apparent clearance will be calculated as CL/F=Dose/AUC(0-inf)
Timepoint [2] 0 0
0-48 hours
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
0-48 hours
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
0-48 hours
Secondary outcome [5] 0 0
Anti-drug Antibody (ADA) titer - ADA titer through to day 28
Timepoint [5] 0 0
Day -1 to day 28
Secondary outcome [6] 0 0
Number of subjects with Adverse Events - Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)
Timepoint [6] 0 0
Study onset till 28 days post dosing
Secondary outcome [7] 0 0
Number of subjects with Adverse Events - Vital Signs (systolic and diastolic blood pressure, pulse rate, temperature and respiratory rates)
Timepoint [7] 0 0
Study onset till 28 days post dosing
Secondary outcome [8] 0 0
Number of subjects with Adverse Events - Clinical laboratory assessments (serum chemistry, hematology, and urinalysis)
Timepoint [8] 0 0
Study onset till 28 days post dosing

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Basic Science
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Kiel
Country [2] 0 0
Germany
State/province [2] 0 0
München
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MedImmune LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03235375
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications