Study identifier:D5670C00009
ClinicalTrials.gov identifier:NCT03347968
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1, Open-label Study to Compare the Pharmacokinetics and Pharmacodynamics of Warfarin and Esmolol in the Absence and Presence of MEDI0382 in Healthy Subjects
Healthy Volunteers
Phase 1
Yes
Warfarin, Esmolol
All
22
Interventional
18 Years - 45 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Mar 2019 by MedImmune, LLC
MedImmune, LLC
-
A Phase 1 study to evaluate the effect of MEDI0382 on pharmacokinetics (PK) and pharmacodynamics (PD) of warfarin and esmolol in healthy participants.
This is a Phase 1 open label, one-sequence, crossover study to evaluate the effect of MEDI0382 on PK and PD of warfarin and esmolol in healthy participants. The safety and tolerability of MEDI0382 in combination with warfarin and esmolol will also be evaluated. Following screening, the study consists of 2 5-day inpatient stays followed by outpatient visits.
Location
Location
Daytona Beach, FL, United States, 32117
Arms | Assigned Interventions |
---|---|
Experimental: MEDI0382 All participants will receive MEDI0382. | Biological/Vaccine: MEDI0382 All participants will receive MEDI0382 |
Active Comparator: Warfarin All participants will receive Warfarin | Drug: Warfarin All participants will receive Warfarin |
Active Comparator: Esmolol All participants will receive Esmolol | Drug: Esmolol All participants will receive Esmolol |
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