Safety and Pharmacokinetics Study of CPL207280 Compound in Healthy Volunteers.
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Volunteers
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentMasking: Double (Participant, Investigator)Masking Description: Only PART B will be double-blindPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Description
This is to be one-centre, single ascending dose and double-blind multiple ascending dose two part study of CPL207280 compound in healthy volunteers. PART A is a single dose, open-label part with CPL207280 compound administered with dose escalation between cohorts.Additionaly assessing the effect of ...
This is to be one-centre, single ascending dose and double-blind multiple ascending dose two part study of CPL207280 compound in healthy volunteers. PART A is a single dose, open-label part with CPL207280 compound administered with dose escalation between cohorts.Additionaly assessing the effect of food and effect of metformin on bioavailability of CPL207280 is to be done in additional cohort. PART B is a multiple, double-blind part with CPL207280 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 CPL207280 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.
Tracking Information
- NCT #
- NCT04622111
- Collaborators
- National Center for Research and Development, Poland
- Investigators
- Not Provided
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