A Phase 1 interventional study of MYK-491 or placebo in Dilated Cardiomyopathy, sponsored by MyoKardia, Inc.. Completed at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-23.
Sponsored by MyoKardia, Inc. (part of Bristol-Myers Squibb) · Phase 1, Interventional, and Treatment
Up to 72 healthy volunteers will be given a single dose of MYK-491 or placebo and be monitored for safety and tolerability over a 7 day period.
Up to 72 healthy volunteers will be given a single dose of MYK-491 or placebo and be monitored for safety and tolerability over a 7 day period. After the 28 day screening period, the eligible subject will be admitted to the clinical site and will receive a single dose of study drug or placebo. Subjects will be confined to the clinical site for five days (Day -1 to Day 4) and will return to the clinic on Day 7 for a safety follow-up.
255 studies on the registry are indexed under Cardiomyopathy, Dilated; 66 are open to participants now.
This study's enrollment of 64 is above the median of 43 across 145 interventional studies indexed under Cardiomyopathy, Dilated.
Browse Cardiomyopathy, Dilated studies →MyoKardia, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
First submitted before MyoKardia, Inc. became part of Bristol-Myers Squibb.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
single-dose, oral suspension
Drug: MYK-491 or placebo
single-dose, oral suspension
Drug: MYK-491 or placebo
Oral suspension
Safety and tolerability assessments will include treatment emergent AEs and SAEs, ECG recordings, vital signs, hs-troponin 1 concentrations, laboratory abnormalities and physical exam abnormalities
Time frame: 7 days
Maximum observed plasma drug concentration (Cmax)
Time frame: 7 days
Maximum observed plasma concentration (Tmax)
Time frame: 7 days
Area under the plasma concentration-time curve (AUC)
Time frame: 7 days
First-order terminal elimination half-life (t1/2)
Time frame: 7 days
Mean retention time (MRT)
Time frame: 7 days
The change from baseline in LVFS, LVEF, LVSV and SET by TTE
Time frame: 7 days
SET while using photoplethysmography
Time frame: 7 days
Relationship between MYK-491 plasma concentrations/PK parameters and PD parameters
Time frame: 7 days
Plasma concentrations of metabolites of MYK-491 in plasma and urine
Time frame: 7 days
Relationship between MYK-491 plasma concentration and QTc interval
Time frame: 7 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in Nov 2017, 10 months.
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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