Microdose Pharmacokinetic Study of PRX-P4-003 In Healthy Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Volunteers
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: In the first arm a fixed order crossover of a PRX-P4-003 followed by administration of the (-)-FCF after a washout period. In the second arm a separate cohort will be administered PRX-P4-003 under fed conditions.Masking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Only males
Description
A crossover study comparing blood concentrations after oral administration of microdoses of (-)-fencamfamine (FCF; 40 µg) or its prodrug form (PRX-P4-003; 100 µg)) in the fasted state will be carried out in 4 healthy male volunteers (Study A). This will be followed by determination of blood concentr...
A crossover study comparing blood concentrations after oral administration of microdoses of (-)-fencamfamine (FCF; 40 µg) or its prodrug form (PRX-P4-003; 100 µg)) in the fasted state will be carried out in 4 healthy male volunteers (Study A). This will be followed by determination of blood concentrations of (-)-fencamfamine in a separate cohort of 4 volunteers following oral administration of a microdose of PRX-P4-003 (100 µg) in a fed state (Study B).
Tracking Information
- NCT #
- NCT04638803
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Kore Liow, MD Hawaii Pacific Neuroscience
Get Well Soon