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

• Status: Completed
• Trial end date: 2018-04-09
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MedImmune LLC
• Treatments: Esmolol; Warfarin

Criteria

Inclusion Criteria:.

• 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 Criteria:

• 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.