NCT01860105

Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Evaluation

Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Open-label, Randomized, Cross-over Evaluation: The AMPHORE Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: The Medicines Company · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Following a first, dose ascending study that enrolled 144 normal healthy volunteers (NHVs), this study, to be conducted in approximately 36 NHVs, will provide pertinent information in determining the dose-response of MDCO-157 for platelet aggregation inhibition and P2Y12 receptor inhibition effects and in selection of doses that match the antiplatelet effects of 300 mg PLAVIX® ®. The study will also provide additional data for pharmacokinetics (PK), safety and tolerability of single doses of MDCO-157.

Conditions

• Pharmacokinetics and Pharmacodynamics in Healthy Volunteers

Interventions

Type	Name	Description
DRUG	MDCO-157	intravenous administration
DRUG	PLAVIX	oral administration

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2013-05-22
• Last updated: 2018-02-22

Locations

1 site across 1 country: France