Safety and Pharmacokinetics Study of CPL500036 Compound in Healthy Volunteers

Celon Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: CPL500036 compound; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03873324

01PDE2018

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

CPL500036

Experimental group

Description:

PART A: 7 cohorts are to receive single dose of IMP. Each participant is to take single dose of IMP. There is to be dose escalation between cohorts. PART B: 4 cohorts are to receive multiple dose of IMP. Each participant is to take IMP once daily for 14 days. There is to be dose escalation between cohorts.

Treatment:

Drug: CPL500036 compound

Placebo

Placebo Comparator group

Description:

PART B: 2 Participants from 4 cohorts (total of 8 people) are to receive masking placebo capsules once daily for 14 days. There is to be dose escalation between cohorts. Participants are to be randomized within cohorts.

Treatment:

Drug: Placebo