Early study checks how well new drug tablet works in healthy people
NCT ID NCT06717269
First seen Jun 24, 2026 · Last updated Jul 29, 2026 · Updated 3 times
Summary
This early-phase study is testing a drug called NX-5948 in 18 healthy adults to see how well a tablet form works compared to a capsule. It also looks at whether food or a common heartburn drug (esomeprazole) changes how the body absorbs NX-5948. The goal is to gather information for future studies, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NX-5948
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
223 people
The number who actually took part.
- Started
-
Nov 2024
- Finished
-
May 2026
- 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 55 years
- Sex
-
Anyone
- Healthy volunteers
-
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.
Key Inclusion Criteria: * Healthy, adult, male or female 19-55 years of age * Continuous non-smoker who has not used nicotine and tobacco-containing products for at least 3 months prior to the first dosing * Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 * Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, or vital signs at the screening visit, as deemed by the Principal Investigator (PI) or designee * Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol. Key Exclusion Criteria: * Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study * Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neoplastic myeloproliferative, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders * History of any gastrointestinal surgery or cholecystectomy that could impact the PK of NX-5948 * History or presence of alcohol or drug abuse within the past 2 years * History or presence of hypersensitivity, angioedema, or idiosyncratic reaction to the study drug(s) or related compounds * History or presence of: * Significant multiple and/or severe allergies, including anaphylactic reaction. * Personal or family history of prolonged QT syndrome or family history of sudden cardiac death. * Evidence of atrial fibrillation, atrial flutter, complete bundle branch block, Wolff Parkinson-White Syndrome, or cardiac pacemaker. * Adrenal insufficiency. * Skin infection. * Female volunteers of childbearing potential * Female volunteer with a positive pregnancy test * Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit * Donation of blood or significant blood loss within 56 days prior to the first dosing * Plasma donation within 7 days prior to the first dosing * History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. * Previous exposure to NX-5948. * Participation in another clinical study within 30 days or within 5 half-lives (if known), prior to the first dosing, whichever is longer. The 30-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study. Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Celerion
Phoenix, Arizona, 85283, United States
-
Celerion
Lincoln, Nebraska, 68502, United States
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