New pill formulation tested for better absorption in healthy volunteers
NCT ID NCT07222878
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new version of NPT 2042 soft-gelatin capsules to see if it is absorbed better than the original version. Eight healthy adults took single doses of both formulations. The goal was to measure how the drug moves through the body, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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8 people
The number who actually took part.
- Started
-
Sep 2025
- Finished
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Nov 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Celerion
Lincoln, Nebraska, 68502, United States
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