Study to Compare Pharmacokinetics & Pharmacodynamics of Warfarin & Esmolol in the Absence & Presence of MEDI0382

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

A Phase 1 study to evaluate the effect of MEDI0382 on PK and PD of warfarin and esmolol in healthy subjects.

Key facts

Study ID

NCT03347968

Run by

MedImmune LLC

People needed

22

Starts

2017-11-27

Expected to finish

2018-04-09

Last updated by the study team

2018-04-25

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
• Receipt of investigational product as part of a clinical study or a GLP-1 analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening.
• Concurrent participation in another study of any kind
• Severe allergy/hypersensitivity to any of the proposed study treatments or excipients.
• History or presence of gastrointestinal (GI), hepatic, or renal disease or any other conditions known to interfere with absorption, distribution, metabolism or excretion of drugs.
• Impaired renal function is defined as estimated glomerular filtration rate (eGFR) < 60 mL/minute/1.73 m2 at screening.
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of screening.
• History of hemophilia, von Willebrand's disease, lupus anticoagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding.

Where it is running

• Research Site — Daytona Beach, Florida, United States

Full record on ClinicalTrials.gov

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