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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT01392703
Eligibility Criteria:
Key Inclusion Criteria:
* Healthy participants, defined as having no clinically relevant deviation from normal in medical history, physical examination, electrocardiogram (ECG) findings, and clinical laboratory tests findings.
* Body mass index of 18 to 32 kg/m\^2, inclusive
* Age from 18 to 55 years
* Men and women who were not of childbearing potential (ie, who were postmenopausal or surgically sterile)
* All women must have had a negative serum or urine pregnancy test result(minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) at screening and within 24 hours prior to dosing with study drug
* Women must not have been breastfeeding
* Sexually active fertile men with female partners of childbearing potential were required to abide by the requirement to use effective birth control for the entire study and for 90 days after the date of last treatment
* Men must have agreed not to donate sperm for the entire study and for 90 days after the day of last study treatment
* Participants must have agreed not to make blood donations, including red blood cells, plasma, platelets, or whole blood, for the entire study and for 8 weeks after the day of last study treatment
Key Exclusion Criteria:
* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) disease of the gastrointestinal (GI) tract that may impact drug absorption and may affect pharmacokinetics of the study drugs or any GI tract surgery that may impact drug absorption
* Any major surgery, as determined by the investigator, within 4 weeks of dosing in Period 1
* Blood transfusion within 4 weeks of study drug administration
* Donation of \>400 mL of blood within 8 weeks prior to study dosing or donation of plasma within 4 weeks prior to study dosing
* Inability to tolerate oral medication
* Inability to tolerate orange juice
* Inability to undergo venipuncture and/or tolerate venous access
* Use of tobacco or nicotine-containing products within 6 months prior to check-in, or positive nicotine test at screening and/or check-in
* Consumption of more than 3 cups of coffee or other caffeine-containing products a day, or 5 cups of tea a day
* Recent (within 6 months of study drug administration) drug or alcohol abuse
* Positive blood screen for hepatitis C antibody; hepatitis B surface antigen; and HIV-1, HIV-2, or HIV antibody
* History of any significant drug allergy or asthma
* Evidence of organ dysfunction or any clinically relevant deviation from normal in physical examination, ECG findings, vital signs, or clinical laboratory test findings.
* Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat ECG:
* PR ≥210 ms
* QRS ≥120 ms
* QT ≥500 ms
* QTcF ≥450 ms
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01392703
Study Brief:
Protocol Section:
NCT01392703