Clinical trial NCT03873324: Safety and Pharmacokinetics Study of CPL500036 Compound in Healthy Volunteers
Official title: One Centre Single Ascending Dose and Double Blind Multiple Ascending Dose, Safety and Pharmacokinetics Phase I Study of CPL500036 Compound in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Celon Pharma SA
Sponsor class: INDUSTRY
Collaborators: name: National Center for Research and Development, Poland
First posted: 2019-03-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 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.

Eligibility 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).

Primary outcomes:
measure: Determination of maximum tolerated dose (MTD) or administration of the maximum dose provided in the protocol after single and multiple oral administration of IMP.
timeFrame: up to 24 hours after single administration of IMP in PART A and up to 24 hours after the last IMP administration in PART B
measure: Safety and tolerability of IMP after single and multiple oral administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring.
timeFrame: up to 14 days in PART A and up to 28 days in PART B of the study
Secondary outcomes:
measure: Cmax - maximum CPL500036 plasma concentration
timeFrame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
measure: AUC(0-72) - area under the plasma concentration - time curve from time 0 to 72h after IMP administration for CPL500036
timeFrame: up to 72 hours after administration of IMP in PART A
measure: AUC(0-24) - area under the plasma concentration - time curve from time 0 to 24h after IMP administration for CPL500036
timeFrame: up to 24 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 and 14 in PART B
measure: AUC(0-inf) - area under the plasma concentration - time curve from time 0 to infinity time for CPL500036
timeFrame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
measure: Tmax - time to reach maximum CPL500036 concentration
timeFrame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
measure: Kel - terminal elimination rate constant
timeFrame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
measure: T1/2 - The plasma elimination half-life for CPL500036 compound
timeFrame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
measure: C (1,t) - CPL500036 concentration
timeFrame: Determined on Day 2, 3, 4, 5, 6, 8, 9, 10, 11, 12 and 13 in PART B.
measure: C (Tmax, t) - CPL500036 concentration
timeFrame: Determined on Day 2, 3, 4, 5, 6, 8, 9, 10, 11, 12 and 13 in PART B.
measure: Amount of CPL500036 in each urine collection sample
timeFrame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
measure: Ae - total amount of CPL500036 excreted in urine
timeFrame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
measure: Clr - renal clearance
timeFrame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
measure: Excretion rate
timeFrame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B
Other outcomes:
Locations:
city: Kajetany
country: Poland
facility: BioResearch Group Sp. z o.o.
state: Nadarzyn
Study officials:
References: