NCT07222878CompletedPhase 1
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 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
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 13 Oct 2025
- Start date
- 29 Sept 2025
- Primary completion date
- 4 Nov 2025
- Lead sponsor
- NeuroPro Therapeutics, Inc.
- Diseases
- Epilepsy, Alzheimer disease
- NCT number
- NCT07222878
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 8
- From 29 Sept 2025 to the primary completion date, 4 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically significant acute illness within 2 weeks prior to Day -1.
- 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.
- Blood donation of \>500 mL or more within 56 days prior to Day -1.
Other illness
- 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.
- History of clinically significant orthostatic hypotension or any vasovagal syncope.
- Presence of clinically significant illness or abnormality on physical examination.
- 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.
Lab values
- Personal or family history of long QT syndrome.
- 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.
Other
- History or evidence of adverse symptoms associated with phlebotomy or blood donation
- Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.
Who the study is looking for
- 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.
Age in the registry: 19 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Celerion Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.