Safety and Pharmacokinetics Study of CPL500036 Compound in Healthy Volunteers

One Centre Single Ascending Dose and Double Blind Multiple Ascending Dose, Safety and Pharmacokinetics Phase I Study of CPL500036 Compound in Healthy Volunteers

The planned study is to determine the safety and pharmacokinetic properties of CPL500036 compound after single and multiple (two weeks) administration in healthy volunteers.

This is to be one-centre, single ascending dose and double-blind multiple ascending dose two part study of CPL500036 compound in healthy volunteers.

PART A is a single dose, open-label part with CPL500036 compound administered with dose escalation between cohorts.

PART B is a multiple, double-blind part with CPL500036 compound administered for 14 days with dose escalation between cohorts. Participants in this part are to be randomized to receive Investigational Medicinal Product (IMP) or placebo in 3:1 ratio.

Safety and pharmacokinetic properties of CPL500036 compound is to be determined following different doses in single oral IMP administration in PART A and different doses of IMP administered orally for two weeks in PART B.

Inclusion Criteria:

• Caucasian female or male,
• Age: 18-55 years old, inclusive,
• Body-mass index (BMI): ≥18.5 kg/m^2 and <29.9 kg/m^2,
• Non-smoker and nonuser of tobacco products for at least 3 months before screening,
• Physical examination without any clinically relevant abnormality,
• Laboratory values not clinically significant,
• Volunteer (or his/her partner) of childbearing potential willingness to use acceptable forms of contraception.

Exclusion Criteria:

• Known allergy or hypersensitivity to other drugs similar in structure or class to CPL500036 compound, or to any excipients of the formulation,
• Any known significant current or past acute or chronic disease or condition,
• Participation in other clinical trial within 90 days preceding the screening,
• Blood drawn within 30 days prior to inclusion to the study (more or equal to 300mL),
• Positive results from pregnancy test for female participants,
• Lactation in women participants,
• Hypotension or hypertension in medical history,
• Long QT interval syndrome or is under the treatment with antiarrhythmic drugs,
• Narcotic, alcohol addiction or abuse,
• Participant who adhere to a special diet (e.g. low calories, vegetarian).