NCT01849094

Evaluating the Safety, Pharmacokinetics and Haemodynamic Effect of a Slow Release Oral Formulation of Milrinone

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: The Alfred · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To determine the pharmacokinetic profile of a new (extended release) formulation of milrinone and to demonstrate evidence of hemodynamic effect Primary: Pharmacokinetic profile - to demonstrate stable plasma levels Secondary (HF cohort) - to demonstrate evidence of haemodynamic benefit Study Design: Open label

Conditions

• Healthy
• Heart Failure

Interventions

Type	Name	Description
DRUG	Milrinone 6mg	Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements
DRUG	milrinone 10mg ER	Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements
DRUG	milrinone 14mg	Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-05-08
• Last updated: 2015-01-14

Locations

2 sites across 1 country: Australia