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:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT02508506
Eligibility Criteria:
Inclusion Criteria:
For all subjects:
* Has a body mass index (BMI) of 18.0-40.0 kg/m\^2 and a total body weight \>50kg
* Agrees to use an approved method of contraception for the duration of the study
* Additional criteria may apply
For subjects with renal impairment:
* Has severe or end stage renal disease, and does not require dialysis
* Has stable renal function for at least 60 days preceding screening
* Additional criteria may apply
Exclusion Criteria:
For all subjects:
* Has any past history or current finding of a clinically significant observed abnormality, psychiatric or medical condition other than renal impairment
* Has a history of gastrointestinal surgery affecting drug absorption or biliary elimination, excluding appendectomy or cholecystectomy
* Is pregnant, planning to become pregnant, or lactating
* Has a history of clinically significant allergy or a hypersensitivity to opioids
* Additional criteria my apply
For subjects with renal impairment:
* Has evidence of compromised respiratory function, seizure disorder, or myasthenia gravis
* Has received a kidney transplant
* Additional criteria may apply
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT02508506
Study Brief:
Protocol Section:
NCT02508506