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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: JoAnn Giannone
  • Phone Number: 919-637-1566
  • Email: joann@npt.io

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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