- Young healthy males, 18-45 years (inclusive) of age
- Healthy as judged by a responsible physician with no clinically significant
abnormality
- Surgically sterile OR agrees to abstain from sexual intercourse with a female partner
OR agrees to use a condom and spermicide during sexual intercourse with a female
partner who uses another form of contraception
- Body weight above 50 kg (Body Mass Index between 19 and 30 kg/m2)
- Non-smokers
- Willing and able to comply with study instructions and commit to all follow-up visits
- Ability to understand, agree to and sign the study Informed Consent Form (ICF)
- History of serious adverse reactions or hypersensitivity to any drug; or who have a
known allergy to any of the test product(s) or any components in the test product(s);
or history of hypersensitivity or allergic reactions to any of the study preparations
as described in the Investigator's Brochure
- Any clinically significant central nervous system, cardiac, pulmonary, metabolic,
renal, hepatic or gastrointestinal conditions
- Abnormal physical findings of clinical significance at the screening examination or
baseline
- History of orthostatic hypotension
- Clinically significant abnormal laboratory values
- Presence or history of allergies requiring acute or chronic treatment
- 12 lead ECG abnormalities
- Major surgical interventions within 6 months of the study
- Has a positive pre-study Hepatitis B surface antigen; positive hepatitis C (HCV)
antibody or detectable HCV ribonucleic acid (RNA); or positive HIV antibody result
- Use of prescription or non-prescription drugs
- Has a history of regular alcohol consumption
- Loss of 500 mL blood or more during the 3 month period before the study
- People that follow vegetarian or vegan diet
- Symptoms of a significant somatic or mental illness in the four week period preceding
drug administration
- History of drug abuse or dependence within 12 months of the study
- The subject has a positive pre-study alcohol or urine drug screen
- Concurrent participation in another drug or device research study or within 60 days of
post participation in another drug or device study
- Considered by the Investigator to be unsuitable candidate for this study