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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT01702493
Eligibility Criteria:
Inclusion Criteria:
* Healthy as determined by a responsible and experienced physician.
* Males between 18 and 65 years of age inclusive, at the time of signing the informed consent.
* Body weight \>=50 kilogram (kg) (110 lbs) and body mass index (BMI) \>=18.
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria:
* Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures or compromise the subject's safety.
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), or aspartate aminotranferase (AST), alanine aminotranferase (ALT), alkaline phosphatase and bilirubin \>1.5 x upper limit of normal (ULN).
* Abnormalities on the Screening or Day -1: electrocardiogram (ECG) that, in the opinion of the investigator, will compromise subject safety in the study or QT corrected using Fridericia's formula (QTcF) \> 450 milliseconds (msec).
* A history of Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV), or positive serology at Screening.
* History of regular alcohol consumption within 6 months of the Screening (Screening visit) and a positive pre-study drug/alcohol screen.
* Participation in a clinical trial and treatment with an investigational product within 3 months prior to Screening visit.
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements.
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that contraindicates their participation.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
* Where participation in the study would result in the inability to donate blood or blood products in excess of 500 milliliter (mL) within a 56 day period.
* Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
* Consumption of red wine, seville oranges, grapefruit or grapefruit juice \[and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices\] from 7 days prior to the first dose of study medication.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01702493
Study Brief:
Protocol Section:
NCT01702493