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:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT05029518
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤59 years old at time of screening.
2. Body mass index (BMI) \>18.5 and \<30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
3. Healthy as defined by:
1. the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
3. the absence of clinically significant history of constipation, diarrhea, or irregular bowel transit in the last 4 weeks.
4. the absence of clinically significant history of irritable bowel syndrome (IBS) of any type.
5. the absence of current or history of ischemic colitis.
6. the absence of any other gastrointestinal disease which could interfere with the absorption of orally-administered medication.
4. Female subjects of non-childbearing potential must be:
1. post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented follicle-stimulating hormone (FSH) levels ≥40 mIU/mL at screening; or
2. surgically sterile (bilateral oophorectomy, hysterectomy or tubal ligation at least 3 months prior to dosing).
5. Sexually active female subjects of childbearing potential and non-sterile male subjects must be willing to use an acceptable contraceptive method throughout the study as detailed in section 11.1.
6. Willing to take off dentures or mouth piercing at the time of dosing (for Treatment A).
7. Able to understand the study procedures and provide signed informed consent form (ICF) to participate in the study.
Exclusion Criteria:
1. Any clinically significant (in the opinion of the Investigator) abnormal finding at physical examination at screening.
2. Any clinically significant (in the opinion of the Investigator) abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
3. Positive pregnancy test or lactating female subject.
4. Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or Day -1.
5. Known allergic reactions to any excipient in the formulations.
6. History of hypersensitivity to 5-hydroxytryptamine 3 receptor (5-HT3) receptor antagonists or agonists.
7. Clinically significant ECG abnormalities (Fridericia's corrected QT interval \[QTcF\] \>450 ms for males and \>470 ms for females).
8. Clinically significant vital signs abnormalities (systolic BP lower than 90 or over 160 mmHg, diastolic BP lower than 50 or over 95 mmHg, or HR less than 45 bpm) at screening.
9. Clinically significant orthostatic vital signs abnormalities such as decrease in systolic BP of 20 mmHg or higher, decrease in diastolic BP of 10 mmHg or higher, or increase in HR of 30 bpm or higher within 3 minutes after passing from a supine to a standing position.
10. History of significant drug abuse within 1 year prior to screening or use of drugs such as marijuana within 3 months prior to the screening visit or drugs such as cocaine, phencyclidine (PCP), crack, opioid derivatives including heroin, and amphetamine derivatives within 1 year prior to screening.
11. History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit that exceeds 14 units of alcohol per week (1 unit = 150 mL of wine, 375 mL of mid strength beer, or 30 mL of distilled alcohol 40%).
12. Use of medications within the timeframes specified in section 11.2.
13. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing or of a biological product within 90 days prior to dosing.
14. Previous participation in a clinical research study involving the administration of SMP-100.
15. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
16. Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that would be likely to interfere with successful completion of the dosing procedure.
17. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT05029518
Study Brief:
Protocol Section:
NCT05029518