A Single-center, Open-label, Single-dose, Three-period, Fixed Sequence Study to Evaluate the Relative Bioavailability of a New Formulation of NPT 2042 Soft-Gelatin Capsules Compared to the Original Formulation of NPT 2042 Soft-Gelatin Capsules Administered Orally to Healthy Adult Participants With Co-administered Agent
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
A Single-center, Open-label, Single-dose, Three-period, Fixed Sequence Study to Evaluate the Relative Bioavailability of a New Formulation of NPT 2042 Soft-Gelatin Capsules
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 65
Healthy Volunteers: t
View:
• Males and females between 19 and 65 years of age, inclusive.
• Body mass index (BMI) of 18 to 35 kg/m2, inclusive, using the following formula: weight (kg)/\[height (m)\]
• A minimum body weight of 50 kg for males and 45 kg for females.
• All females must have a negative serum pregnancy test at Screening and a negative serum pregnancy test upon admission to the clinical research center.
• Females must be of non-child-bearing potential.
• Male participants with female partners of reproductive potential must agree to protocol specifications.
Locations
United States
Nebraska
Celerion
RECRUITING
Lincoln
Contact Information
Primary
Charles Moser
chuckmoser.nlc@gmail.com
919-675-0604
Backup
JoAnn Giannone
joann@npt.io
919-637-1566
Time Frame
Start Date: 2025-09-29
Estimated Completion Date: 2025-11-15
Participants
Target number of participants: 8
Treatments
Experimental: NPT 2042 80mg (Reference formulation) in Fasted State
NPT 2042 80mgSingle-dose, reference formulation, given in fasted state.
Experimental: NPT 2042 80mg (Test formulation) in Fasted State
NPT 2042 80mgSingle-dose, test formulation, given in fasted state.
Experimental: NPT 2042 80mg (Test Formulation) in Fasted State with co-administered agent
NPT 2042 80mgSingle-dose, test formulation, given in fasted state with co-administered agent.
Related Therapeutic Areas
Sponsors
Leads: NeuroPro Therapeutics, Inc.