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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT06601257
Eligibility Criteria:
Inclusion Criteria:
1. 24 healthy obese participants within three obese class groups; BMI 30-34.9 kg/m2 (n=8), BMI 35-39.9 kg/m2 (n=8), and BMI ≥ 40 kg/m2 (n=8)
2. Male or female adults age 18 to 50 years
3. Weight ≥ 80 kg
4. Estimated creatinine clearance of 60 mL/min to 119 mL/min (n=12) or ≥ 120 mL/min (n=12) (based on the Cockcroft-Gault equation and dosing weight)
Exclusion Criteria:
1. Pregnant or lactating females
2. Significant clinical illness within 3 weeks prior to screening
3. History of severe allergic diseases including drug allergies, with the exception of seasonal allergies
4. Patients initiated on GLP1 agonists
5. Any other factor, condition, or disease, including but not limited to cardiovascular, renal, hepatic, or gastrointestinal disorders that may, in the opinion of the Investigator, jeopardize the safety of the participant or impact the validity of the study results.
6. History of drug addiction or alcohol abuse within the past 12 months
7. Any clinically significant abnormal lab values (Chemistry and Complete Blood Count) during screening
8. Participants unwilling or unable to receive vancomycin by intravenous infusion
9. Individuals with a history of psychiatric or neurological illness, including seizure disorders
10. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
11. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg
12. Pulse rate \<50 beats/minute or \>100 beats/minute.
13. History of hypersensitivity or infusion reaction to vancomycin, cetirizine, or famotidine
14. Participants with underlying hearing loss
15. Participants that are taking ototoxic drugs
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06601257
Study Brief:
Protocol Section:
NCT06601257