EpilepsyPhase 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 Phase 1 study testing NPT 2042 (Reference formula/Formulation 1) and NPT 2042 (Test formula/Formulation 2) in people with Epilepsy and Alzheimer Disease, run by NeuroPro Therapeutics, Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Alzheimer Disease, Epilepsy Intractable
- What is being tested?
- NPT 2042 (Reference formula/Formulation 1) and NPT 2042 (Test formula/Formulation 2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2025to 4 Nov 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Epilepsy, Alzheimer Disease, Epilepsy Intractable
- Being tested
- NPT 2042 (Reference formula/Formulation 1), NPT 2042 (Test formula/Formulation 2)
- Keywords
- CNS Disorder, Seizure Disorder
- Medical subject headings
- Epilepsy, Alzheimer Disease, Drug Resistant Epilepsy, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPT 2042 (Reference formula/Formulation 1)Drug
In Period 1 Day 1, participants will receive Formulation 1 in a fasted state (Treatment A).
NPT 2042 (Test formula/Formulation 2)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 (Test formula/Formulation 2)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).
| Study group | Role | What they receive |
|---|---|---|
| NPT 2042 80mg (Reference formulation) in Fasted State | Experimental | NPT 2042 80mgSingle-dose, reference formulation, given in fasted state. Receives: Drug: NPT 2042 (Reference formula/Formulation 1) |
| NPT 2042 80mg (Test formulation) in Fasted State | Experimental | NPT 2042 80mgSingle-dose, test formulation, given in fasted state. Receives: Drug: NPT 2042 (Test formula/Formulation 2) |
| NPT 2042 80mg (Test Formulation) in Fasted State with co-administered agent | Experimental | NPT 2042 80mgSingle-dose, test formulation, given in fasted state with co-administered agent. Receives: Drug: NPT 2042 (Test formula/Formulation 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Plasma NPT 2042 PK endpoints including the Cmax (NPT 2042 only).
Measured: 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.
Plasma NPT 2042 PK endpoints including the Tmax (NPT 2042 only).
Measured: 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.
Plasma NPT 2042 PK endpoints including the t½ (NPT 2042 only).
Measured: 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.
Plasma NPT 2042 PK endpoints including the AUClast (NPT 2042 only).
Measured: 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.
Plasma NPT 2042 PK endpoints including the AUCinf (NPT 2042 only).
Measured: 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.
Plasma NPT 2042 PK endpoints including the CL/F (NPT 2042 only).
Measured: 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.
The Frel calculations will be based on Cmax and AUCinf values for NPT 2042.
Measured: Baseline (Day -1) as compared to Tx. period 1 (Day 1) and Tx. Period 2 (Day 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start29 Sep 2025
- Primary completion4 Nov 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroPro Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222878
- Sponsor's protocol ID
- CL-103
- Status last verified
- Apr 2026
- First submitted
- 13 Oct 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No