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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT01514968
Eligibility Criteria:
Inclusion Criteria:
* Male and female healthy volunteers, 18 to 45 years of age inclusive
* Body mass index (BMI) 18.0 to 32.0 kg/m2
* Weight \>/= 50 kg
* Healthy status defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
* Nonsmoker
* Females of childbearing potential and males and their female partner(s) of childbearing potential must agree to use 2 forms of contraception, 1 of which must be a barrier method, during the study and for 90 days after the last drug administration (acceptable barrier forms are condom and diaphragm, acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device and/or spermicide)
Exclusion Criteria:
* Pregnant or lactating females
* Positive results for drugs of abuse in the urine at screening or prior to admission to the clinical site during any study period
* Positive for hepatitis B, hepatitis C or HIV infection
* Current smokers or subjects who have discontinued smoking less than 6 months prior to the first dose of study medication
* Use of hormonal contraceptives (birth control pills, patches or injectable, implantable devices) within 30 days before the first dose of study medication
* Routine chronic use of more than 2 g acetaminophen daily
* Use of any investigational drug or device within 30 days of screening (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
* History of clinically significant disease or disorder
* History of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01514968
Study Brief:
Protocol Section:
NCT01514968