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 @ 1:09 PM
Ignite Modification Date:
2025-12-24 @ 1:09 PM
NCT ID:
NCT00984061
Eligibility Criteria:
Inclusion Criteria:
* Healthy, non-smoking, adult volunteers, male and female, 18 to 45 years of age, weighing at least 55 kg and within 15% of ideal body weight, with hemoglobin \>/=12 g/dL.
* Female volunteers must be sexually abstinent for 14 days prior to the first dose and throughout the study or using acceptable birth control methods (prior to and during the study), including being postmenopausal or surgically sterile (or sexual activity restricted to a partner that is surgically sterile), hormonal contraception, an IUD, or barrier methods with spermicide. Additionally, they will be advised to remain sexually inactive or to keep the same birth control method for at least 14 days following the last dose of colchicine.
Exclusion Criteria:
* Subjects who are pregnant or lactating
* Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV)
* Have history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease; have used any drugs or substances known to inhibit or induce CYP enzymes and/or P-gp within 30 days prior to the first dose and throughout the study
* Recent (2-year) history of evidence of alcoholism or drug abuse
* Subjects who donated 50-499 ml of blood within 30 days and more than 499 ml within 56 days prior to the first dose; subjects who have donated in excess of 500 ml of blood in 14 days, 1500 ml or blood in 180 days, or 2500 ml of blood in 1 year (through completion of the study)
* Have participated in another clinical trial within 30 days prior to dosing
* Known and documented drug allergies to colchicine or macrolide antibiotics.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00984061
Study Brief:
Protocol Section:
NCT00984061