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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT01626651
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) between 18 and 30 kg/m2, and body weight not less than 50 kg
* Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
* Non-smoker
* Must agree to use an adequate contraception method during the study and minimally 3 months after the last dose of ibrutinib, and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
* Signed an informed consent document
Exclusion Criteria:
* History of or current clinically significant medical illness
* Clinically significant abnormal physical examination, vital signs or electrocardiogram (ECG)
* Clinically significant abnormal values for laboratorial tests
* Use of any prescription or nonprescription medication, except for acetaminophen, within 3 days before the first dose of the study drug is schedule
* History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 2 years
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01626651
Study Brief:
Protocol Section:
NCT01626651