CY6021-To see if CK-3773274 is safe and tolerable in adults with oHCM

• Research type

  Research Study

• Full title

  A Multi-Center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK­3773274 in Adults with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

• IRAS ID

  272939

• Contact name

  Perry Elliot

• Contact email

  perry.elliott@ucl.ac.uk

• Sponsor organisation

  Cytokinetics Inc.

• Eudract number

  2019-002785-12

• Clinicaltrials.gov Identifier

  NCT04219826

• Clinicaltrials.gov Identifier

  44360, NIHR

• Duration of Study in the UK

  1 years, 4 months, 16 days

• Research summary

  This study aims to determine if an investigational medicine called CK-3773274 is safe and tolerable in adult patients with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricalur Outflow Tract Obstruction (oHCM), meaning they have an abnormal thickness in their heart, affecting their blood flow. CK-3773274 has only been tested in healthy volunteers so far. This study would like to find out what doses of this investigational medicine can be safely taken in a patient population.
  Participants in this study will be randomly assigned (like flipping a coin) into 1 of 2 groups. One group will receive a placebo, which looks like the investigational drug but contains no drug ingredient, while the other group will receive CK-3773274 in varying doses. The chance of receiving placebo is 1 in 3 (33%). The chance of receiving CK-3773274 is 2 in 3 (66%). Participants will not have a choice in what group they are placed.
  This study will be conducted by trained investigators in NHS hospital sites. Participants on this study will be adults (18-70 years old) who have been diagnosed with oHCM and meet a number of other health criteria. The study will begin with a 4 week screening period which will determine if participants are able to participate. Once this has been determined, a 10 week treatment period will begin where participants will be given either placebo or CK-3773274. After this a 4 week follow up is conducted. The total duration of the study for a participant is approximately 18 weeks,

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  20/WM/0055

• Date of REC Opinion

  8 May 2020

• REC opinion

  Further Information Favourable Opinion