A Pharmacokinetic and Pharmacodynamic Study of Omecamtiv Mecarbil in Healthy Volunteers

Inclusion criteria

• Subject is male
• Subject is aged between 18 and 50 years inclusive.
• Subject has given signed informed consent.
• Subject's Body Mass Index (BMI) is between 18 and 30 kg/m2 inclusive.
• Subject weighs less than 100 kg.
• Subject is considered to be in good health in the opinion of the investigator, as determined by:

• A pre-study physical examination with no clinically significant abnormalities.
• Vital signs within normal ranges (supine after 3 minutes rest - heart rate: 40 to 80 bpm; systolic BP: 100 to 140 mmHg; diastolic BP: 50-90 mmHg; respiration rate: 8 to 18 breaths per minute; oxygen saturation: 96-100%)
• An ECG with no clinically significant abnormalities.
• Subject's pre-study clinical laboratory findings are within normal range or if outside of the normal range not deemed clinically significant in the opinion of the investigator.
• Cardiac troponin I is less than the upper limit of the laboratory reference range.
• A screening echocardiogram demonstrates normal cardiac function, an ejection fraction of between 40% and 70% with no significant valvular regurgitation (grade 1) and/or stenosis and images are deemed to be of good quality by the sonographer.

Exclusion criteria

• Subject has had a clinically significant illness in the four weeks before screening.
• Use of prescribed mediations in the 3 weeks prior to dosing or over-the-counter preparations (including vitamin supplements and herbal remedies) for 7 days prior to dosing, except paracetamol which will be allowed up to 48 hours prior to dosing.
• Subject has a significant history of drug/solvent abuse or a positive drugs of abuse test at screening.
• Subject with a history of alcohol abuse or currently drinks in excess of 28 units per week.
• Subject smokes more than 5 cigarettes (or equivalent) per day.
• Subject is not willing to refrain from caffeine/xanthine containing products from 48 hours prior to the screening medical and admission on Day -1 until the post study medical.
• Subject is in the opinion of the investigator not suitable to participate in the study.
• Subject who has participated in any clinical study with an investigational drug/device within three months prior to the first day of dosing.
• Subject who has a positive result of HIV screen, Hepatitis B screen or Hepatitis C screen.
• Subject has had a serious adverse reaction or significant hypersensitivity to any drug.
• Subject has donated 500 ml or more of blood within the month prior to screening.
• Subject has a history of cardiovascular disease or family history of premature cardiovascular disease or death.