NCT03873324

Safety and Pharmacokinetics Study of CPL500036 Compound in Healthy Volunteers

One Centre Single Ascending Dose and Double Blind Multiple Ascending Dose, Safety and Pharmacokinetics Phase I Study of CPL500036 Compound in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Celon Pharma SA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	CPL500036 compound	IMP is a capsule with CPL500036 as an Active Pharmaceutical Ingredient (API).
DRUG	Placebo	matching placebo capsules

Timeline

• Start date: 2018-12-20
• Primary completion: 2019-09-16
• Completion: 2019-09-16
• First posted: 2019-03-13
• Last updated: 2019-10-04

Locations

1 site across 1 country: Poland