HealthyPhase 1/2NCT01849094
Evaluating the Safety, Pharmacokinetics and Haemodynamic Effect of a Slow Release Oral Formulation of Milrinone
A Phase 1/2 study testing Milrinone 6mg, milrinone 10mg ER and milrinone 14mg in people with Healthy and Heart Failure, run by The Alfred at 2 sites in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Heart Failure
- What is being tested?
- Milrinone 6mg, milrinone 10mg ER and milrinone 14mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesAustralia
- Study dates
- May 2013to Dec 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part A: Healthy volunteers; Part B: Heart failure patients Inclusion Criteria - Part A Healthy Volunteers
- Participants must:
- Provide written informed consent prior to any study procedure and agree to adhere to all protocol requirements
- Be aged between 18 to 45 years old inclusive at the time of consent
- Be in good general health without clinically significant medical history
- Have a body mass index (BMI) between 19- 30 kg/m2 inclusive
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- Documented 12-lead ECG with no clinically significant abnormalities, as determined by the Investigator
- No clinically significant abnormalities in screening or Day 0 laboratory tests, as determined by the Investigator;
- 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
- Negative Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C Screening test results
- Participants must:
- Provide written informed consent prior to any study procedure and agree to adhere to all protocol requirements
- Heart Failure patients with LVEF less than45%
- NYHA II-III
- Stable medications (for greater than 48hrs)
- Systolic BP greater than 90
Who cannot join
- Participants will not be enrolled if they meet any of the following criteria:
- If female, pregnant or lactating
- Receipt of any investigational agent or drug within 30 days or 5 half-lives (whichever is longer) prior to the first dose of Investigational product
- Use of prescription drugs within 4 weeks prior to first dosing. Subjects who have used over the counter medication excluding paracetamol, topical over the counter medications and routine vitamins but including megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within 7 days of first dosing, unless agreed as non-clinically relevant by the Principal Investigator
- No clinically relevant findings in the medical history, laboratory examination and physical examination, especially with regards to cardiovascular system and renal function
- A positive urine test for drugs of abuse or alcohol at Screening or on the day of admittance to the Study Unit
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- Normal dietary habits
- Any major surgical procedure within one month of entry into the study
- Have difficulties communicating reliably with the Investigator or unlikely to co-operate with the requirements of the study.
- Any other condition which in the view of the Investigator is likely to interfere with study or put the subject at risk.
- Unstable heart failure including NYHA IV symptoms
- Treatment with intravenous inotropes or mechanical circulatory support.
- Unstable rhythm including frequent non-sustained ventricular tachycardia or poorly controlled atrial fibrillation (ventricular rate >100).
- Severe renal impairment Cr>200umol/L or dialysis.
- Life-threatening haematological, hepatic or pulmonary disease.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Alfred Hospital
Melbourne, Victoria, 3004
Nucleus Network
Melbourne, Victoria, 3004
About this study
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
- Being tested
- Milrinone 6mg, milrinone 10mg ER, milrinone 14mg
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milrinone 6mgDrug
Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements
milrinone 10mg ERDrug
Also called Milirone
Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements
milrinone 14mgDrug
Also called Milirone
Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements
| Study group | Role | What they receive |
|---|---|---|
| Milrinone 6mg | Experimental | single oral dose of 6mg ER milrinone tablet (Part A).
1. single intravenous infusion of milrinone (per Alfred Hospital protocol. 50ug/kg loading dose over 15 mins followed by infusion at 0.375 ug/kg/min for 6 hrs) - Part B. Receives: Drug: milrinone 10mg ER; Drug: milrinone 14mg |
| Milrinone 10mg ER | Active comparator | single oral dose of 10 mg ER milrinone tablet (Part A) single oral dose of 10 mg ER milrinone tablet (Part B) Receives: Drug: Milrinone 6mg; Drug: milrinone 14mg |
| Milrinone 14mg | Active comparator | single oral dose of 14 mg ER milrinone tablet (Part A) single dose of 14 mg ER milrinone tablet 4. single oral dose of 18 mg ER milrinone tablet (if the group average plasma milrinone levels is less than 150 ug/L with 15 mg dose) - (Part B) Receives: Drug: Milrinone 6mg; Drug: milrinone 14mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile - to demonstrate stable plasma levels
Laboratory Analysis: Plasma milrinone concentration
Measured: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
Secondary outcomes (1)
(Heart Failure cohort) - to demonstrate evidence of haemodynamic benefit
ECG and Blood pressure and HR Monitoring Swan Ganz insertion for haemodynamic measurements (RA volume , RVSP, CO, PA, PAWP)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof David Kaye, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849094
- Sponsor's protocol ID
- DK-MIL-1
- Status last verified
- Jan 2015
- First submitted
- 30 Apr 2013
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety, Pharmacokinetics and Haemodynamic Effect of a Slow Release Oral Formulation of Milrinone
- ClinicalTrials.gov ID
- NCT01849094
- Acronym / sponsor ID
- DK-MIL-1
- Conditions
- Healthy, Heart Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Milrinone 6mg | Experimental | Drug: milrinone 10mg ER, Drug: milrinone 14mgsingle oral dose of 6mg ER milrinone tablet (Part A). 1. single intravenous infusion of milrinone (per Alfred Hospital protocol. 50ug/kg loading dose over 15 mins followed by infusion at 0.375 ug/kg/min for 6 hrs) - Part B. |
| Milrinone 10mg ER | Active comparator | Drug: Milrinone 6mg, Drug: milrinone 14mgsingle oral dose of 10 mg ER milrinone tablet (Part A) single oral dose of 10 mg ER milrinone tablet (Part B) |
| Milrinone 14mg | Active comparator | Drug: Milrinone 6mg, Drug: milrinone 14mgsingle oral dose of 14 mg ER milrinone tablet (Part A) single dose of 14 mg ER milrinone tablet 4. single oral dose of 18 mg ER milrinone tablet (if the group average plasma milrinone levels is less than 150 ug/L with 15 mg dose) - (Part B) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Part A: Healthy volunteers; Part B: Heart failure patients Inclusion Criteria - Part A Healthy Volunteers
- Provide written informed consent prior to any study procedure and agree to adhere to all protocol requirements
- Be aged between 18 to 45 years old inclusive at the time of consent
- Be in good general health without clinically significant medical history
- Have a body mass index (BMI) between 19- 30 kg/m2 inclusive
Key exclusion criteria (15 listed)
- If female, pregnant or lactating
- Receipt of any investigational agent or drug within 30 days or 5 half-lives (whichever is longer) prior to the first dose of Investigational product
- Use of prescription drugs within 4 weeks prior to first dosing. Subjects who have used over the counter medication excluding paracetamol, topical over the counter medications and routine vitamins but including megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within 7 days of first dosing, unless agreed as non-clinically relevant by the Principal Investigator
- No clinically relevant findings in the medical history, laboratory examination and physical examination, especially with regards to cardiovascular system and renal function
- A positive urine test for drugs of abuse or alcohol at Screening or on the day of admittance to the Study Unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milrinone 6mgAdministration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements | Drug | Milrinone 10mg ER, Milrinone 14mg |
| milrinone 10mg ERAlso: MilironeAdministration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements | Drug | Milrinone 6mg |
| milrinone 14mgAlso: MilironeAdministration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements | Drug | Milrinone 10mg ER, Milrinone 14mg, Milrinone 6mg |
Primary outcome
Pharmacokinetic profile - to demonstrate stable plasma levels
Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
Laboratory Analysis: Plasma milrinone concentration
1 secondary outcome
(Heart Failure cohort) - to demonstrate evidence of haemodynamic benefit
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Milrinone 6mg, milrinone 10mg ER and milrinone 14mg in people with Healthy and Heart Failure, run by The Alfred at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic profile - to demonstrate stable plasma levels (time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015; AzTrials last refreshed its copy on 7 Nov 2026.