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

April 1, 2026 updated by: NeuroPro Therapeutics, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Celerion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Clinically significant acute illness within 2 weeks prior to Day -1.
  • Presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
  • Presence of an active malignancy or a malignancy of any type within the past 5 years, other than squamous cell or basal cell carcinoma of the skin.
  • Clinically significant acute or chronic infection or known inflammatory condition.
  • Personal or family history of long QT syndrome.
  • History or evidence of adverse symptoms associated with phlebotomy or blood donation
  • History of clinically significant orthostatic hypotension or any vasovagal syncope.
  • Plans for surgery or other medical procedures during the study.
  • Clinically significant past or current medical or surgical history that could interfere with treatment.
  • Participation in an investigational drug or device study within 30 days or five half-lives, whichever is longer [90 days for biologics], prior to dosing.
  • Presence of clinically significant illness or abnormality on physical examination.
  • Presence of clinically significant ECG abnormality at Screening, including any QT interval corrected for heart rate (QTc) using Fridericia formula (QTcF) ≥470 msec.
  • Ongoing liver disease or unexplained liver function test (LFT) elevations, defined as alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), or alkaline phosphatase (ALP) greater than the upper limit of normal (ULN).
  • Any other clinically significant laboratory results, as judged by the investigator.
  • History or presence of clinically significant hypersensitivity (e.g. systemic or cutaneous) as judged by the investigator to NPT 2042.
  • History of substance abuse or current use of any drugs of abuse.
  • Blood donation of >500 mL or more within 56 days prior to Day -1.
  • Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NPT 2042 80mg (Reference formulation) in Fasted State
NPT 2042 80mgSingle-dose, reference formulation, given in fasted state.
Drug: NPT 2042 (Reference formula/Formulation 1)
In Period 1 Day 1, participants will receive Formulation 1 in a fasted state (Treatment A).
Experimental: NPT 2042 80mg (Test formulation) in Fasted State
NPT 2042 80mgSingle-dose, test formulation, given in fasted state.
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).
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Time Frame: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
Plasma NPT 2042 PK endpoints including the Cmax (NPT 2042 only).
Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Time Frame: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
Plasma NPT 2042 PK endpoints including the Tmax (NPT 2042 only).
Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Time Frame: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
Plasma NPT 2042 PK endpoints including the t½ (NPT 2042 only).
Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Time Frame: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
Plasma NPT 2042 PK endpoints including the AUClast (NPT 2042 only).
Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Time Frame: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
Plasma NPT 2042 PK endpoints including the AUCinf (NPT 2042 only).
Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Time Frame: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
Plasma NPT 2042 PK endpoints including the CL/F (NPT 2042 only).
Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
To calculate the Frel and 90% confidence intervals for Formulation 1 (Reference) vs Formulation 2 (Test) both administered in a fasted state.
Time Frame: Baseline (Day -1) as compared to Tx. period 1 (Day 1) and Tx. Period 2 (Day 4)
The Frel calculations will be based on Cmax and AUCinf values for NPT 2042.
Baseline (Day -1) as compared to Tx. period 1 (Day 1) and Tx. Period 2 (Day 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroPro Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2025

Primary Completion (Actual)

November 4, 2025

Study Completion (Actual)

November 4, 2025

Study Registration Dates

First Submitted

October 13, 2025

First Submitted That Met QC Criteria

October 29, 2025

First Posted (Actual)

October 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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