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 @ 9:47 PM
Ignite Modification Date:
2025-12-24 @ 9:47 PM
NCT ID:
NCT01511432
Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects (male and female of non-childbearing potential) between the ages of 18 and 55 years
* Non-childbearing potential female subjects
* Male subjects and female partners must agree to use at least 2 methods of contraception
* Subjects with a body mass index (BMI) of 18 to 30 kg/m2 and weigh \>50 kg at the Screening Visit.
Exclusion Criteria:
* Subjects with a positive test result for hepatitis B, hepatitis C, or HIV
* Subjects with a significant history of any illness, as deemed important by the investigator or any condition possibly affecting drug absorption
* Subjects with a positive urine screen for drugs of abuse
* Subjects with a history of regular alcohol consumption
* Subjects treated with an investigational drug within 30 days
* For Part A only: Subjects with 12-lead ECG QTcF \>450 msec (males) or QTcF \>470 msec (females) at the Screening Visit
* Subjects who use prescription and/or nonprescription medications or vitamins and/or dietary supplements
* Subjects who have made a blood donation of approximately 1 pint (500 mL) within 56 days prior to the first dose of study drug
* Subjects who have a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug
* Subjects on hormone replacement therapy (HRT) must discontinue such therapy 28 days prior to the first dose of study drug
* Subjects who have a habit of using tobacco or nicotine containing products within 6 months before the Screening Visit
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01511432
Study Brief:
Protocol Section:
NCT01511432