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

NCT ID: NCT07222878

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-29
• Study Completion Date: 2025-11-15

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NPT 2042 80mg (Reference formulation) in Fasted State

NPT 2042 80mgSingle-dose, reference formulation, given in fasted state.

Group Type: EXPERIMENTAL

NPT 2042 (Reference formula/Formulation 1)

Intervention Type: DRUG

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

NPT 2042 80mg (Test formulation) in Fasted State

NPT 2042 80mgSingle-dose, test formulation, given in fasted state.

Group Type: EXPERIMENTAL

NPT 2042 (Test formula/Formulation 2)

Intervention Type: DRUG

Following a 3-day wash out, in Period 2 Day 1, participants will receive Formulation 2 in a fasted state (Treatment B).

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.

Group Type: EXPERIMENTAL

NPT 2042 (Test formula/Formulation 2)

Intervention Type: DRUG

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).

Interventions

NPT 2042 (Reference formula/Formulation 1)

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

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NeuroPro Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Celerion

Lincoln, Nebraska, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Charles Moser

Role: CONTACT

chuckmoser.nlc@gmail.com

919-675-0604

JoAnn Giannone

Role: CONTACT

joann@npt.io

919-637-1566

Facility Contacts

Elsie Moorehead

Role: primary

Elsie.Moorehead@celerion.com

402-437-4844

Other Identifiers

CL-103

Identifier Type: -

Identifier Source: org_study_id