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 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT01440335
Eligibility Criteria:
-INCLUSION CRITERIA:
1. Healthy men and women
2. Age: 21-60
3. Screening laboratory evaluations with no clinically significant abnormal results:
* Chem-20 panel plus troponin
* Complete blood count with differential and platelet count
* Urinalysis with microscopic examination
* Electrocardiogram
* Echocardiogram: 2D + Doppler
* Urine drug screen
* Urine pregnancy test
4. BMI 24-30
5. Able to provide written informed consent
6. Agree to not participate in other clinical trials during the study period
7. If in child-bearing age and participating in sexual activity that could lead to pregnancy, agree to use a medically accepted method of contraception for a woman for at least 1 month prior to enrollment and continuing 1 month after completion of the fifth study visit, and for a man beginning immediately after the second study visit and continuing for 3 months after completion of the fifth study visit.
EXCLUSION CRITERIA:
1. Resting sitting blood pressure greater than 140/90 mm Hg, resting heart rate greater than 100 bpm
2. Abnormal laboratory examination (ALT and AST greater than 1.5 times the normal range, other labs within 10% of normal range); abnormal troponin screening level will be an exclusion.
3. Clinically significant abnormality on EKG (major Q waves, evidence of heart block, significant conduction disease, QT prolongation)
4. Clinically significant abnormality on Echocardiogram (ejection fraction less than 50 percent, valvular heart disease of moderate severity, pulmonary hypertension with PASP greater than 40mm Hg)
5. Evidence of illicit drug use or alcohol abuse
6. History of Human Immunodeficiency Virus (HIV) infection
7. History of active or chronic Hepatitis B and/or C infection
8. History of malignancy (other than non-invasive skin cancer)
9. History of coronary disease, conduction system disease, pacemaker, atrial fibrillation/flutter, ventricular tachycardia/fibrillation, significant valvular disease, or other cardiovascular disease
10. History of asthma -- reactive airway disease
11. History of seizures or other neurologic diseases
12. History of liver or renal diseases
13. History of gastrointestinal or endocrine disorders (other than mild dyspepsia)
14. Medication use other than occasional use of over-the-counter drugs and/or contraceptives
15. Any medication or herbal drug use within the past 3 days before study participation other than contraceptives
16. Any medical history that, in the opinion of the investigator(s), will make participation of the subject in the study unsafe
17. Participation in another clinical trial involving any pharmacologic agents or blood loss within the past 30 days
18. Donation of blood or blood products within the past 56 days
19. Women who are of childbearing potential and not using acceptable forms of contraception will be excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT01440335
Study Brief:
Protocol Section:
NCT01440335