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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT01088932
Eligibility Criteria:
Inclusion Criteria:
1. Males and non-pregnant, non-lactating females of non-childbearing potential. Female patients should be either post-menopausal or surgically sterile.
2. Age ≥18 and ≤55 years.
3. Body mass index (BMI) of 18.5 to 34.0 kg/m2, inclusive, and a total body weight of \>50kg (110 pounds).
4. In good health as determined by medical history, a baseline physical examination, vital signs, clinical laboratory tests and electrocardiogram (ECG) measurement.
5. Subject is willing and able to sign written informed consent prior to receipt of any study medication or beginning study procedures.
6. Subject is willing and able to follow instructions, comply with the protocol requirements and make all required study visits.
Exclusion Criteria:
1. Pregnant or lactating females, or females of childbearing potential.
2. Subject is positive for HIV, hepatitis B surface antigen or hepatitis C antibody tests at screening.
3. Subject with a positive urine test for drugs of abuse or alcohol at screening or at admission to the clinic on study Day -1.
4. Evidence of any out-of range laboratory value at screening that has not been reviewed, approved and documented as not clinically significant by the Principal Investigator.
5. Subject who has resting supine blood pressure outside of a systolic blood pressure range of 90-140 mmHg or a diastolic blood pressure outside a range of 50-90 mmHg on two consecutive measurements taken up to 10 minutes apart.
6. Subject who has resting supine pulse rate greater than 100 bpm or less than 50 bpm on two consecutive measurements taken up to 10 minutes apart.
7. Subject has taken any alcohol within 48 hours of ANY study-related activities AND cannot abstain from drinking alcohol during the entire duration of the subject's study participation.
8. Subject has used any tobacco products in the past 12 months.
9. A history of significant drug allergy or systemic allergic disease (e.g., urticaria, atopic dermatitis).
10. A general medical or psychological condition or behavior, including current substance dependence or abuse that, in the opinion of the investigator, might not permit the subject to complete the study or sign the informed consent.
11. Any clinically significant abnormality on screening resting 12-lead ECG (e.g., heart block, conduction disorders, ventricular and/or atrial arrhythmias).
12. Any other condition or clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening that, in the opinion of the Principal Investigator or the Physician Sub-Investigator, would make the subject unsuitable for the study or put them at additional risk.
13. Routine or PRN consumption of medications or herbal supplements that the subject is unable or unwilling to discontinue during the study.
14. Inability to understand or follow study instructions.
15. Treatment with an investigational drug within 30 days preceding the first dose of study medication.
16. Known allergy or hypersensitivity to the investigational study drug/placebo components.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01088932
Study Brief:
Protocol Section:
NCT01088932