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 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT01249118
Eligibility Criteria:
Inclusion Criteria
* Within body mass index range 18.5 to 29.9 kilograms per square meter (kg/m\^2)
* In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs
* Clinical laboratory evaluations within the reference range for the test laboratory
* Negative test for selected drugs of abuse at Screening and at each Check-in
* Negative hepatitis panel and anti-hepatitis C virus and negative human immunodeficiency virus (HIV) antibody screens
* Healthy males and females of non-child-bearing potential or who agree to use effective contraception
Exclusion Criteria
* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy, hernia repair, and cholecystectomy will be allowed
* History or presence of an abnormal ECG
* History of alcoholism or drug addiction prior to period 1 check-in
* Use of any tobacco-containing or nicotine-containing products prior to period 1 check-in
* Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 28 days or 5 half-lives, whichever is longer, prior to period 1 check-in
* Use of any prescription medications/products, including proton pump inhibitors, within 14 days prior to period 1 check-in
* Poor peripheral venous access
* Any acute or chronic condition that would limit the participants ability to complete and/or participate in this clinical study
* Female participant is pregnant, lactating, or breastfeeding
* Predisposing factors to retinal vein occlusion (RVO)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01249118
Study Brief:
Protocol Section:
NCT01249118