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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT01211860
Eligibility Criteria:
Inclusion Criteria:
Basic requirements
1. Healthy male and female subjects 18 to 75 years of age, inclusive at the time of dosing
2. Body mass index (BMI) between 22 and 35 kg/m2
Specific laboratory test results
3. Fasting triglyceride ≥ 150 mg/dL and ≤ 1500 mg/dL
4. Fasting glucose ≤ 110 mg/dL
5. HbA1c ≤ 6.0 %
Exclusion Criteria:
Medications: recent, current, anticipated
1. Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month)
2. Thiazide diuretics within 2 weeks prior to Screening Visit
History of allergic reaction or significant intolerance to:
3. Diazoxide
4. Thiazides
5. Sulfonamides
Lifestyle changes
6. Subjects intending to change exercise habits, and/or quit smoking
Specific diagnoses, medical conditions and history
7. Known type I or III hyperlipidemia
8. Known type 1 DM
9. Known type 2 DM
10. Any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the investigational drug, according to the Investigator
Specific laboratory test results
11. Any relevant biochemical abnormality interfering with the assessments of the investigational drug
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01211860
Study Brief:
Protocol Section:
NCT01211860