Status:
COMPLETED
A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects
Lead Sponsor:
MedImmune LLC
Conditions:
Renal Insufficiency
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
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 subj...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2018
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03235375
Start Date
October 27 2017
End Date
April 24 2018
Last Update
May 1 2018
Active Locations (4)
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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