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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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 - Placebo

Experimental: MYK-461 - Oral Tablet x 28 days

Placebo comparator: Placebo - Oral Tablet x 28 days


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
Timepoint [1] 0 0
63 days
Secondary outcome [1] 0 0
Determination of pharmacokinetic parameters
Timepoint [1] 0 0
63 days
Secondary outcome [2] 0 0
Determination of pharmacokinetic parameters
Timepoint [2] 0 0
63 days
Secondary outcome [3] 0 0
Determination of pharmacokinetic parameters
Timepoint [3] 0 0
63 days
Secondary outcome [4] 0 0
Determination of pharmacokinetic parameters
Timepoint [4] 0 0
63 days
Secondary outcome [5] 0 0
Characterize pharmacodynamic parameters
Timepoint [5] 0 0
63 days
Secondary outcome [6] 0 0
Characterize pharmacodynamic parameters
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
Sex
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
1/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
60
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02480296