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 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT02571192
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 50 years, inclusive, at the time of consent.
2. Must be considered healthy. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, thyroid panel (includes T3, T4 and TSH at Screening only), blood chemistry, coagulation and urinalysis
3. Must have a body mass index between 18.0-30.0kg/m² inclusive with a body weight \>50 kg (110 lbs).
4. Ability to swallow all investigational product.
5. A minimum of 1 bowel movement per day.
Exclusion Criteria:
1. History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gallbladder removal, gastric bypass surgery, ileal resection, any small intestinal resection,or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.
2. Current or relevant history of physical or psychiatric illness.
3. Known or suspected intolerance or hypersensitivity to the investigational product, or closely-related compounds, or any of the stated ingredients.
4. Significant illness, as judged by the investigator, within 2 weeks of the dose of investigational product.
5. Known history of alcohol or other substance abuse within the last year.
6. Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to the dose of investigational product.
7. Within 30 days prior to the dose of investigational product:
* Have used an investigational product (if elimination half-life is \<6 days, otherwise 5 half-lives).
* Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
* Have had any substantial changes in eating habits, as assessed by the investigator.
8. Confirmed systolic blood pressure \>139mmHg or \<89mmHg, and diastolic blood pressure \>89mmHg or \<49mmHg.
9. Twelve-lead ECG demonstrating QTc \>450 msec at screening. If QTc exceeds 450msec, the ECG should be repeated 2 more times and the average of the 3 QTc values should be used to determine the subject's eligibility.
10. A positive screen for drugs of abuse at Screening or a positive screen for alcohol or drugs of abuse at Check-in (Day -1).
11. Male subjects who consume more than 21 units of alcohol per week or 3 units of alcohol per day.
12. A positive human immunodeficiency virus antibody screen, hepatitis B surface antigen, or hepatitis C virus antibody screen.
13. Use of tobacco in any form
14. Routine consumption of more than 2 units of caffeine per day
15. Current use of any medication including over-the-counter, herbal, or homeopathic preparations
16. An inability to follow a standardized diet and meal schedule or inability to fast
17. Have participated in a \[14C\]-study within the last 6 months prior to the dose of investigational product.
18. Exposure to clinically significant radiation within 12 months prior to the dose of investigational product
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02571192
Study Brief:
Protocol Section:
NCT02571192