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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02480296




Registration number
NCT02480296
Ethics application status
Date submitted
17/06/2015
Date registered
24/06/2015
Date last updated
22/03/2017

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of MYK-461 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
MYK461-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MYK-461
Treatment: Drugs - Placebo

Experimental: MYK-461 - Oral Tablet x 28 days

Placebo Comparator: Placebo - Oral Tablet x 28 days


Treatment: Drugs: MYK-461


Treatment: Drugs: Placebo
Placebo comparator

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety as measured by the incidence of adverse events - Incidence of adverse events
Timepoint [1] 0 0
63 days
Secondary outcome [1] 0 0
Determination of pharmacokinetic parameters - maximum concentration (Cmax)
Timepoint [1] 0 0
63 days
Secondary outcome [2] 0 0
Determination of pharmacokinetic parameters - time of the maximum measured concentration (Tmax)
Timepoint [2] 0 0
63 days
Secondary outcome [3] 0 0
Determination of pharmacokinetic parameters - area under the concentration time curve (AUC)
Timepoint [3] 0 0
63 days
Secondary outcome [4] 0 0
Determination of pharmacokinetic parameters - half-life (t1/2)
Timepoint [4] 0 0
63 days
Secondary outcome [5] 0 0
Characterize pharmacodynamic parameters - echocardiogram assessment
Timepoint [5] 0 0
63 days
Secondary outcome [6] 0 0
Characterize pharmacodynamic parameters - peak oxygen consumption
Timepoint [6] 0 0
63 days

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any structural abnormalities on echocardiography

- Positive results of HIV test and/or seropositive for HCV or HBV

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MyoKardia, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02480296
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Grimm, MD
Address 0 0
MyoKardia, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications