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 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT00966602
Eligibility Criteria:
Inclusion Criteria:
* Male or female subject between 18 and 55 years of age, inclusive
* Body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive
* Subjects of child-bearing potential and who are sexually active must meet contraception requirements
* Female subject must have a negative serum pregnancy test at screening, Day -1, and throughout the study
Exclusion Criteria:
* History of any illness that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject. This may include but is not limited to a significant history of cardiovascular, central nervous system, hepatobiliary or renal disease, or a history of mental illness
* Participated in a clinical study involving administration of either an investigational or a marketed drug within 60 days or 7 terminal half-lives (whichever is longer) before the Screening visit
* Subject who has received VX-770 or VX-809 in a previous clinical study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00966602
Study Brief:
Protocol Section:
NCT00966602