Safety and Pharmacokinetics Study of CPL500036 Compound in Healthy Volunteers

• Status: Completed
• Trial end date: 2019-09-16
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Celon Pharma SA
• Collaborator: National Center for Research and Development, Poland

Criteria

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).