A Phase 1 interventional study of MYK-461 in Hypertrophic Cardiomyopathy, sponsored by MyoKardia, Inc.. Completed at 7 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-09-14.
Sponsored by MyoKardia, Inc. (part of Bristol-Myers Squibb) · Phase 1, Interventional, and Treatment
Among 21 studies testing MYK-461 in Cardiomyopathy, Hypertrophic — 3 open to participants now, 7 under way, 1 of them phase 3. MYK-461 · Cardiomyopathy, Hypertrophic.
Among the 21 studies testing MYK-461 in Cardiomyopathy, Hypertrophic, this one is the 20th largest by enrollment, is the only one that started in 2014, is one of 5 in phase 1, and was the 1st registered.
363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.
Browse Cardiomyopathy, Hypertrophic studies →3 of the 21 studies testing MYK-461 in Cardiomyopathy, Hypertrophic are open now, in 2 countries. Recruiting first, the newest first:
University of Manchester · Sites in United Kingdom
Ages 18+
Second Affiliated Hospital, Zhejiang University, School of Medicine · Sites in China
Ages 18–75
Second Affiliated Hospital of Nanchang University
Ages 18+
By country, each count listing its studies:
MYK-461: first FDA approval 2022 (CAMZYOS), first EMA approval 2023. What it is approved for, and how studies give it, is on its page →
Of the 81 Cardiomyopathy, Hypertrophic studies recruiting now, 55 (68%) set no upper age limit and 8 (10%) stop at 75 or younger; 21 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 4 · Phase 3 7 · Phase 4 4
First in 2014; this study’s year is marked. 1 started in 2014.
This study's enrollment of 15 is below the median of 60 across 180 interventional studies indexed under Cardiomyopathy, Hypertrophic.
Median enrollment 75 across the 21 interventional studies. Of the 14 that completed or were terminated, 9 (64%) have results posted.
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17 of 21 have an industry lead sponsor. The 7 most frequent:
This study is registered under MyoKardia, Inc., one of the names counted as Bristol-Myers Squibb. Under that name alone:
MyoKardia, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
31 studies in Cardiomyopathy, Hypertrophic by Bristol-Myers Squibb: 9 open now, 14 under way, 1 of them phase 3. Of 17 finished, 8 (47%) have results posted.
Among the 31 studies in Cardiomyopathy, Hypertrophic by Bristol-Myers Squibb, this one is the 15th largest by enrollment of the 16 interventional ones that give a count, is the only one that started in 2014, is one of 4 in phase 1, and was the 1st registered.
Bristol-Myers Squibb’s Cardiomyopathy, Hypertrophic studies by the year they started, since 2014.
None of the studies under way reaches primary completion within a year.
Among the 21 studies testing MYK-461 in Cardiomyopathy, Hypertrophic, from their registry updates:
Among Bristol-Myers Squibb’s 31 in Cardiomyopathy, Hypertrophic:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects. This is a sequential group, single ascending (oral) dose study in NYHA Class I, II, or III patient volunteers aged 18-65 years.
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: MYK-461
Safety: Incidence of adverse events
Time frame: 28 Days
Determination of pharmacokinetics parameters as measured by Cmax
maximum concentration (Cmax)
Time frame: 28 Days
Determination of pharmacokinetics parameters as measured by Tmax
time of the maximum measured concentration (Tmax)
Time frame: 28 Days
Determination of pharmacokinetics parameters as measured by AUC
area under the concentration-time curve (AUC)
Time frame: 28 Days
Determination of pharmacokinetics parameters as measured by t1/2
half-life (t1/2)
Time frame: 28 Days
The record gives a start of Dec 2014, a primary completion of Mar 2016 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: MYK-461
Cardiomyopathy, Hypertrophic →