Safety and Pharmacokinetics Study of CPL500036 Compound in Healthy Volunteers

NCT03873324 | Completed Phase 1

• 1 other identifier: 01PDE2018
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Determination of maximum tolerated dose (MTD) or administration of the maximum dose provided in the protocol after single and multiple oral administration of IMP.

  MTD is defined as the highest dose for which no more than 1 of the 6 treated volunteers (less than 1/3) exhibits dose limiting toxicity (DLT).

  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

• Safety and tolerability of IMP after single and multiple oral administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring.

  Participants are to be closely observed to assure maximal safety and to collect occurrence of all adverse events. All participants are to be monitored for clinically relevant changes in physical examination, vital signs, 12-lead ECG assessment and deviations from normal in clinical laboratory results (complete blood count, blood chemistry, urinalysis). To follow-up on all study participants telephone calls with a request for information regarding their health condition are to be made.

  up to 14 days in PART A and up to 28 days in PART B of the study

Secondary Outcomes (13)

• Cmax - maximum CPL500036 plasma concentration

  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

• AUC(0-72) - area under the plasma concentration - time curve from time 0 to 72h after IMP administration for CPL500036

  up to 72 hours after administration of IMP in PART A

• AUC(0-24) - area under the plasma concentration - time curve from time 0 to 24h after IMP administration for CPL500036

  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

• AUC(0-inf) - area under the plasma concentration - time curve from time 0 to infinity time for CPL500036

  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

• Tmax - time to reach maximum CPL500036 concentration

  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

Study Arms (2)

CPL500036

EXPERIMENTAL

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.

Drug: CPL500036 compound

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

CPL500036 compound DRUG

IMP is a capsule with CPL500036 as an Active Pharmaceutical Ingredient (API).

CPL500036

Placebo DRUG

matching placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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).

Sponsors & Collaborators

• Celon Pharma SA: lead
• National Center for Research and Development, Poland: collaborator

Study Sites (1)

BioResearch Group Sp. z o.o.

Kajetany, Nadarzyn, 05-830, Poland

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Only PART B will be double-blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: December 20, 2018
• Primary Completion: September 16, 2019
• Study Completion: September 16, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Locations

PL (1)