Status:
COMPLETED
Study to Compare Pharmacokinetics & Pharmacodynamics of Warfarin & Esmolol in the Absence & Presence of MEDI0382
Lead Sponsor:
MedImmune LLC
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
A Phase 1 study to evaluate the effect of MEDI0382 on PK and PD of warfarin and esmolol in healthy subjects.
Detailed Description
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 subjects. The safety and tolerability of MEDI0382 in comb...
Eligibility Criteria
Inclusion
- .
- Healthy volunteers aged ≥ 18 to 45 years
- BMI between 18 -30 kg/m2
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception
Exclusion
- 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.
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03347968
Start Date
November 27 2017
End Date
April 9 2018
Last Update
April 25 2018
Active Locations (1)
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1
Research Site
Daytona Beach, Florida, United States, 32117