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
- Are there results?
- None posted in the registry
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
Show all 18Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07222878
- Acronym / sponsor ID
- CL-103
- Conditions
- Epilepsy, Alzheimer Disease, Epilepsy Intractable
- Keywords
- CNS Disorder, Seizure Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NeuroPro Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 30 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NPT 2042 80mg (Reference formulation) in Fasted State | Experimental | Drug: NPT 2042 (Reference formula/Formulation 1)NPT 2042 80mgSingle-dose, reference formulation, given in fasted state. |
| NPT 2042 80mg (Test formulation) in Fasted State | Experimental | Drug: NPT 2042 (Test formula/Formulation 2)NPT 2042 80mgSingle-dose, test formulation, given in fasted state. |
| NPT 2042 80mg (Test Formulation) in Fasted State with co-administered agent | Experimental | Drug: NPT 2042 (Test formula/Formulation 2)NPT 2042 80mgSingle-dose, test formulation, given in fasted state with co-administered agent. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPT 2042 (Reference formula/Formulation 1)In Period 1 Day 1, participants will receive Formulation 1 in a fasted state (Treatment A). | Drug | NPT 2042 80mg (Reference formulation) in Fasted State |
| 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 80mg (Test formulation) in Fasted State |
| 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). | Drug | NPT 2042 80mg (Test Formulation) in Fasted State with co-administered agent |
Primary outcome
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).
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).
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).
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).
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).
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.