MYK-461-002 SAD in healthy volunteers

• Research type

  Research Study

• Full title

  Safety, Tolerability, Preliminary Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of MYK-461 In Healthy Volunteers

• IRAS ID

  169343

• Contact name

  James Ritter

• Contact email

  james.ritter@quintiles.com

• Sponsor organisation

  MyoKardia Inc

• Eudract number

  2014-003593-16

• Duration of Study in the UK

  0 years, 8 months, 12 days

• Research summary

  MYK-461 is a drug that may be useful in the treatment of hypertrophic cardiomyopathy. Cardiomyopathy is a disorder of the heart muscle. Hypertrophic cardiomyopathy (HCM)is a genetic condition where the heart muscle becomes thickened.

  The purpose of this study is to examine the safety and in particular the effects on the heart, tolerability and the way the body handles (absorbs, distributes, breaks down and excretes) MYK-461 following various increasing single oral doses in healthy volunteers. This study will be the first time MYK-461 is given to healthy human volunteers.

  This study will involve a single admission of six days and five nights, plus several day visits to the clinical research outpatient unit.

• REC name

  HSC REC A

• REC reference

  14/NI/1140

• Date of REC Opinion

  29 Dec 2014

• REC opinion

  Further Information Favourable Opinion