RecruitingPhase 1NCT07222878

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


Sponsor

NeuroPro Therapeutics, Inc.

Enrollment

8 participants

Start Date

Sep 29, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different capsule formulations of the same drug, NPT 2042, to see if the new version is absorbed by the body in the same way as the original. It is a safety and pharmacology study in healthy volunteers — there is no disease being treated. **You may be eligible if...** - You are a healthy adult between 19 and 65 years old - You have a body mass index (BMI) between 18 and 35 - You weigh at least 50 kg (if male) or 45 kg (if female) - Women must not be able to become pregnant (post-menopausal or permanently sterilized) - You are willing to follow all study procedures and attend all required visits **You may NOT be eligible if...** - You have a significant ongoing medical condition (heart, lung, kidney, liver, or neurological disease) - You have a history of cancer in the past 5 years (other than minor skin cancer) - You have a personal or family history of an abnormal heart rhythm condition called long QT syndrome - You have donated more than 500 mL of blood in the past 56 days - You have used recreational drugs recently or have a history of substance abuse - You have participated in another drug trial within the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNPT 2042 (Reference formula/Formulation 1)

In Period 1 Day 1, participants will receive Formulation 1 in a fasted state (Treatment A).

DRUGNPT 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).

DRUGNPT 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).


Locations(1)

Celerion

Lincoln, Nebraska, United States

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NCT07222878


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