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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT01398293
Eligibility Criteria:
Inclusion Criteria:
* Adult healthy volunteers, 18 - 60 years of age
* Female subjects must be surgically sterile or post-menopausal
* Male subjects and their partners of child-bearing potential must use to methods of contraception for the duration of the study and for three months after the last drug administration
* Agree to abstain from strenuous exercise for three days before dosing and throughout the study (including washout period and follow-up visit)
Exclusion Criteria:
* History or evidence of any clinically significant disease or disorder
* Pregnant or lactating women
* Male partners of women who are lactating or trying to become pregnant
* Current smokers or subjects who have discontinued smoking less than six months prior to first dosing
* Positive alcohol breath test; suspicion of regular consumption of drugs of abuse
* Positive for hepatitis B, hepatitis C or HIV infection
* Participation in an investigational drug, biologic, or device study within three months before first study drug administration
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01398293
Study Brief:
Protocol Section:
NCT01398293