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 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
NCT ID:
NCT01876966
Eligibility Criteria:
Inclusion Criteria:
* if of childbearing potential or if male, use a highly effective method of birth control.
* Able to comply with protocol requirements.
* A BMI (weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2, extremes included.
* healthy on the basis of a medical evaluation
* Non-smoking for at least 3 months prior to selection.
Exclusion Criteria:
* previously demonstrated clinically significant allergy, hypersensitivity or intolerance to any of the investigational medications or its excipients
* Use of concomitant medication, including over-the-counter products and dietary supplements.
* Having participated in more than 1 study (single or multiple dose) with ETR (TMC125), DRV (TMC114), dapivirine (TMC120) and/or rilpivirine (TMC278, formerly known as R278474), or having developed a rash, erythema or urticaria while participating in a study with the aforementioned compounds.
* A positive pregnancy test or breast feeding at screening or on Day 1.
* Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the patient or prevent the patient from meeting or performing study requirements
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01876966
Study Brief:
Protocol Section:
NCT01876966