HealthyPhase 1NCT02480296
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of MYK-461 in Healthy Volunteers
A Phase 1 study testing MYK-461 in people with Healthy, run by MyoKardia, Inc. at 1 site in Australia.
Trial summary
The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of MYK-461 in human subjects. This is a randomized, double-blind, placebo-controlled, sequential group, multiple ascending (oral tablet) dose study in healthy volunteers aged 18-55 years. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MYK-461
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2015to Oct 2016
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal body mass index (BMI)
- Normal LVEF
- Normal electrocardiogram (ECG)
- Females must be non pregnant, non lactating and, if sexually active, be using an acceptable birth control method from the time of first dose through 3 months after the last dose of study drug
Who cannot join
- Any structural abnormalities on echocardiography
- Positive results of HIV test and/or seropositive for HCV or HBV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled, Ascending Multiple Oral Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MYK-461 in Healthy Volunteers
The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of MYK-461 in human subjects. This is a randomized, double-blind, placebo-controlled, sequential group, multiple ascending (oral tablet) dose study in healthy volunteers aged 18-55 years.
- Conditions
- Healthy
- Being tested
- MYK-461, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MYK-461Drug
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| MYK-461 | Experimental | Oral Tablet x 28 days Receives: Drug: MYK-461 |
| Placebo | Placebo comparator | Oral Tablet x 28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by the incidence of adverse events
Incidence of adverse events
Measured: 63 days
Secondary outcomes (6)
Determination of pharmacokinetic parameters
maximum concentration (Cmax)
Measured: 63 days
Determination of pharmacokinetic parameters
time of the maximum measured concentration (Tmax)
Measured: 63 days
Determination of pharmacokinetic parameters
area under the concentration time curve (AUC)
Measured: 63 days
Determination of pharmacokinetic parameters
half-life (t1/2)
Measured: 63 days
Characterize pharmacodynamic parameters
echocardiogram assessment
Measured: 63 days
Characterize pharmacodynamic parameters
peak oxygen consumption
Measured: 63 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016
- Study completionOct 2016
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- MyoKardia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Grimm, MD, Study director, MyoKardia, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480296
- Sponsor's protocol ID
- MYK461-003
- Status last verified
- Mar 2017
- First submitted
- 17 Jun 2015
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Randomized, Placebo-controlled, Ascending Multiple Oral Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MYK-461 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02480296
- Acronym / sponsor ID
- MYK461-003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- MyoKardia, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Jun 2015 (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.
The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of MYK-461 in human subjects. This is a randomized, double-blind, placebo-controlled, sequential group, multiple ascending (oral tablet) dose study in healthy volunteers aged 18-55 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MYK-461 | Experimental | Drug: MYK-461Oral Tablet x 28 days |
| Placebo | Placebo comparator | Drug: PlaceboOral Tablet x 28 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Normal body mass index (BMI)
- Normal LVEF
- Normal electrocardiogram (ECG)
- Females must be non pregnant, non lactating and, if sexually active, be using an acceptable birth control method from the time of first dose through 3 months after the last dose of study drug
Key exclusion criteria (2 listed)
- Any structural abnormalities on echocardiography
- Positive results of HIV test and/or seropositive for HCV or HBV
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 |
|---|---|---|
| MYK-461 | Drug | MYK-461 |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
Safety as measured by the incidence of adverse events
Time frame: 63 days
Incidence of adverse events
6 secondary outcomes
Determination of pharmacokinetic parameters
Time frame: 63 days
Determination of pharmacokinetic parameters
Time frame: 63 days
Determination of pharmacokinetic parameters
Time frame: 63 days
Determination of pharmacokinetic parameters
Time frame: 63 days
Characterize pharmacodynamic parameters
Time frame: 63 days
Characterize pharmacodynamic parameters
Time frame: 63 days
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 22 Mar 2017.
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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.
Michael Grimm, MD study director
MyoKardia, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MYK-461 in people with Healthy, run by MyoKardia, Inc. at 1 site 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 4 inclusion and 2 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 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Safety as measured by the incidence of adverse events (time frame: 63 days). 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 22 Mar 2017.