Status:
COMPLETED
Safety and Pharmacokinetics Study of CPL500036 Compound in Healthy Volunteers
Lead Sponsor:
Celon Pharma SA
Collaborating Sponsors:
National Center for Research and Development, Poland
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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.
Detailed Description
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 CPL5...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2019
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03873324
Start Date
December 20 2018
End Date
September 16 2019
Last Update
October 4 2019
Active Locations (1)
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1
BioResearch Group Sp. z o.o.
Kajetany, Nadarzyn, Poland, 05-830