Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT06717269
Eligibility Criteria:
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, vital signs, or 12-lead safety ECGs at the screening visit, as deemed by the 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT06717269
Study Brief:
Protocol Section:
NCT06717269