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

MedImmune

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Esmolol; Biological: MEDI0382; Drug: Warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03347968

D5670C00009

Details and patient eligibility

About

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

Full 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 combination with warfarin and esmolol will also be evaluated. Following screening, the study consists of 2 5-day inpatient stays followed by outpatient visits.

Enrollment: 22 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 3 patient groups

MEDI0382

Experimental group

Description:

All participants will receive MEDI0382.

Treatment:

Biological: MEDI0382

Warfarin

Active Comparator group

Description:

All participants will receive Warfarin

Treatment:

Drug: Warfarin

Esmolol

Active Comparator group

Description:

All participants will receive Esmolol

Treatment:

Drug: Esmolol