NCT07222878

Study to Evaluate the Relative Bioavailability of a New Formulation of NPT 2042 Soft-Gelatin Capsules Compared to the Original Formulation of NPT 2042

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: NeuroPro Therapeutics, Inc. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Epilepsy
• Alzheimer Disease
• Epilepsy Intractable

Interventions

Type	Name	Description
DRUG	NPT 2042 (Reference formula/Formulation 1)	In Period 1 Day 1, participants will receive Formulation 1 in a fasted state (Treatment A).
DRUG	NPT 2042 (Test formula/Formulation 2)	Following a 3-day wash out, in Period 2 Day 1, participants will receive Formulation 2 in a fasted state (Treatment B).
DRUG	NPT 2042 (Test formula/Formulation 2)	Following a 4-day wash out, in Period 3 Day 1, participants will receive Formulation 2 in a fasted state with co-administered agent (Treatment C).

Timeline

• Start date: 2025-09-29
• Primary completion: 2025-11-04
• Completion: 2025-11-04
• First posted: 2025-10-30
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study