A study to evaluate pharmacokinetics, safety and tolerability of MEDI0382 in Renal Impairment participants
Study identifier:D5670C00008
ClinicalTrials.gov identifier:NCT03235375
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Renal Insufficiency
Phase
Phase 1
Healthy volunteers
No
Study drug
MEDI0382
Sex
All
Actual Enrollment
37
Study type
Interventional
Age
18 Years - 85 Years
Date
Study Start Date: 27 Oct 2017
Primary Completion Date: 24 Apr 2018
Study Completion Date: 24 Apr 2018
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Mar 2019 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group 1: CrCl < 20 mL/min Participants with end stage renal disease (ESRD) or severe renal impairment, not yet on dialysis with estimated creatinine clearance (CrCl) less than (<) 20 millilitre per minute (mL/min) will receive a single subcutaneous (SC) dose of 100 micrograms (μg) MEDI0382 under fasted condition on Day 1. | Drug: MEDI0382 Participants will receive a single SC dose of 100 μg MEDI0382 under fasted condition on Day 1. |
| Experimental: Group 2: CrCl >= 20 and < 30 mL/min Participants with severe renal impairment with estimated CrCl greater than or equal to (>=) 20 and < 30 mL/min will receive a single SC dose of 100 μg MEDI0382 under fasted condition on Day 1. | Drug: MEDI0382 Participants will receive a single SC dose of 100 μg MEDI0382 under fasted condition on Day 1. |
| Active Comparator: Group 3: Healthy Participants Healthy participants (control group) with normal renal function (CrCl >= 90 mL/min) will receive a single SC dose of 100 μg MEDI0382 under fasted condition on Day 1. | Drug: MEDI0382 Participants will receive a single SC dose of 100 μg MEDI0382 under fasted condition on Day 1. |
| Experimental: Group 4a: CrCl >= 30 and < 45 mL/min Participants with moderate renal impairment with estimated CrCl >= 30 and < 45 mL/min will receive a single SC dose of 100 μg MEDI0382 under fasted condition on Day 1. | Drug: MEDI0382 Participants will receive a single SC dose of 100 μg MEDI0382 under fasted condition on Day 1. |
| Experimental: Group 4b: CrCl >= 45 and < 60 mL/min Participants with moderate renal impairment with CrCl >= 45 and < 60 mL/min will receive a single SC dose of 100 μg MEDI0382 under fasted condition on Day 1. | Drug: MEDI0382 Participants will receive a single SC dose of 100 μg MEDI0382 under fasted condition on Day 1. |
