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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT02382666
Eligibility Criteria:
Main Inclusion Criteria:
* Subject must be a healthy male or female aged 18 to 55 years at Screening
* A female subject must have a negative pregnancy test at Screening and on Day -1.
* A female subject of childbearing potential must agree to use an accepted method of birth control (excluding hormonal birth control methods) from Screening through 30 days after final study drug administration.
* Subject must have a body mass index (BMI) from 18.5 to 32.0 kg/m2 and a weight of
≥ 50 kg at Screening.
* Subject must be able to provide informed consent after risks and benefits have been explained. Subject must also be willing and able to comply with the protocol requirements.
* Subject must be in general good health as determined by the Investigator based on pre-study medical, medication, and surgical history; physical examination; and clinical laboratory tests.
Main Exclusion Criteria:
* Subject must not have been dosed with test drug or blinded study drug in another investigational study within 30 days or 5 half-lives of the biologic activity of the test drug, whichever is longer, before the time of first study dose.
* Subject must not have a history of hypersensitivity to rolapitant IV or any of its excipients or who have completed a study visit as part of a previous rolapitant study within the 6 months prior to first study drug administration (Day
* Subject must not have poor venous access or consider venipuncture intolerable.
* Subject must not have a history of significant complications or anxiety associated with the IV administration of medications that, in the opinion of the Investigator, could make the subject unable to complete dosing requirements.
* Subject must not be pregnant or lactating.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02382666
Study Brief:
Protocol Section:
NCT02382666