NCT03347968

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	MEDI0382	All participants will receive MEDI0382
DRUG	Warfarin	All participants will receive Warfarin
DRUG	Esmolol	All participants will receive Esmolol

Timeline

• Start date: 2017-11-27
• Primary completion: 2018-04-09
• Completion: 2018-04-09
• First posted: 2017-11-20
• Last updated: 2018-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study