Healthy, Heart Failure
Conditions
Brief 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
Interventions
DRUGMilrinone 6mg
Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements
DRUGmilrinone 10mg ER
Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements
DRUGmilrinone 14mg
Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements
Sponsors
The Alfred
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Part A: Healthy volunteers; Part B: Heart failure patients Inclusion Criteria - Part A Healthy Volunteers Participants must: 1. Provide written informed consent prior to any study procedure and agree to adhere to all protocol requirements 2. Be aged between 18 to 45 years old inclusive at the time of consent 3. Be in good general health without clinically significant medical history 4. Have a body mass index (BMI) between 19- 30 kg/m2 inclusive 5. Documented 12-lead ECG with no clinically significant abnormalities, as determined by the Investigator 6. No clinically significant abnormalities in screening or Day 0 laboratory tests, as determined by the Investigator; 7. Female subjects of reproductive potential must have a negative serum pregnancy (β-HCG) test at screening and a negative urine pregnancy test at Day 0 prior to dosing. Female subjects must also be non-lactating 8. Negative Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C Screening test results Inclusion Criteria - Part B Heart Failure Patients Participants must: 1. Provide written informed consent prior to any study procedure and agree to adhere to all protocol requirements 2. Heart Failure patients with LVEF less than45% 3. NYHA II-III 4. Stable medications (for greater than 48hrs) 5. Systolic BP greater than 90
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic profile - to demonstrate stable plasma levels | 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours | Laboratory Analysis: Plasma milrinone concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| (Heart Failure cohort) - to demonstrate evidence of haemodynamic benefit | 6 hours | ECG and Blood pressure and HR Monitoring Swan Ganz insertion for haemodynamic measurements (RA volume , RVSP, CO, PA, PAWP) |
Countries
Australia
Outcome results
None listed