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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT05212402
Eligibility Criteria:
Inclusion Criteria:
* body mass index of 19.0 to 34.9 kg/m2 (normal weight through Class I obesity)
* Agree to refrain from alcohol consumption for at least 48 hours prior to each visit.
* Willing to practice acceptable measures of birth control and sexually transmitted infections prevention by using double-barrier contraceptive measures (both males and females) throughout the study duration.
* Willing and able to agree to the requirements and restrictions of this study including fasting before blood draw on all visits for laboratory assessment.
* Willing to give voluntary consent, be able to understand and read the questionnaires, carry out all study-related procedures, communicate effectively with the study staff, and agree to allow any study related evaluations.
Exclusion Criteria:
* Have a known sensitivity or allergy to any of the investigational products or their ingredients.
* Female participants who are lactating, pregnant or planning to become pregnant during the study as confirmed at the baseline (visit 2) or male participants of reproductive potential in a heterosexual relationship planning a pregnancy as confirmed at the baseline visit.
* Documented medical history of immune disorder (such as Human immunodeficiency Virus/Acquired immunodeficiency syndrome), hepatitis B or hepatitis C, or reported immune disorder diagnosis.
* Active psychiatric disorder requiring hospitalization within the 12 months prior to screening or currently on medication(s) to treat any psychiatric disorder(s).
* Any cognitive impairment that would, in the opinion of the Investigator, preclude study participation or compliance with study procedures (e.g., Alzheimer's, dementia).
* History of malignancy or those with any first-degree relatives with a history of cancer (e.g., familial cancer disorders) within 5 years.
* History of clinically significant cardiovascular, respiratory, renal, cerebrovascular, metabolic, pulmonary, gastrointestinal, neurological, hematological, autoimmune, lymphatic, psychiatric, chronic pain and sleep disorders, hepatobiliary (with the exception of Gilbert's syndrome or asymptomatic gallstones) or endocrine disorders, including individuals with Type I or Type II diabetes, or other clinically significant medical condition that, in the opinion of the Investigator, may preclude safe study participation.
* Participants with controlled or uncontrolled hypertension including stage 1 hypertension (systolic blood pressure ≥129 mmHg and diastolic blood pressure ≥89 mmHg).
* Participants who are on medications as prescribed for any of the aforementioned exclusionary criteria. Participants on stable dose of thyroid medication (no dosage changes within last 3 months) are acceptable.
* Consumption of prescription or non-prescription: angiotensin converting enzyme inhibitors, angiotensin receptor blockers, barbiturates, cocaine, ethanol, selective serotonin reuptake inhibitor, protease inhibitors, warfarin, sildenafil, theophylline, tricyclic antidepressants and any other medications
* Receipt or use of an investigational product in another research study within 30 days or 5 half lives (whichever is longer) prior to baseline (visit 2) or currently participating in another study
* Receipt or use of an investigational product in another research study within 30 days or 5 half lives (whichever is longer) prior to baseline (visit 2) or currently participating in another study
* Current or recent use (within one month prior to visit 2) of cannabis (e.g., marijuana) or cannabis related products (e.g., CBD) in any ingestible or inhalable forms.
* Positive urine drug test for THC or drugs of abuse (Amphetamine, cocaine, marijuana, methamphetamine, and opiates) at baseline (visit 2).
* Safety blood tests at screening more than 2 times the upper limit of normal (ULN) for liver or kidney function tests.
* Safety blood tests at screening more than 2 times the upper limit of normal (ULN) for liver or kidney function tests.
* Fasting blood glucose of ≥160 mg/dL (after a repeat that confirms the original result) at screening.
* Any other condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05212402
Study Brief:
Protocol Section:
NCT05212402