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

NCT07222878 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-04-03

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • NeuroPro Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-29
Primary Completion
2025-11-04
Completion
2025-11-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07222878 on ClinicalTrials.gov