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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT01059851
Eligibility Criteria:
Inclusion Criteria:
Impaired Renal Function Participants:
* Females of reproductive potential must have a negative pregnancy test and agree to use (and/or have their partner use) two acceptable methods of birth control
* Body Mass Index (BMI) ≤40 kg/m\^2
* Diagnosis of renal insufficiency
Healthy Participants:
* Females of reproductive potential must have a negative pregnancy test and agree to use (and/or have their partner use) two acceptable methods of birth control
* Body Mass Index (BMI) ≤40 kg/m\^2 and is matched for BMI ± 5 units to his/her corresponding renal participant
* In general good health
* Matched for age ± 10 years to his/her corresponding renal participant
Exclusion Criteria:
Impaired Renal Function Participants:
* Is mentally or legally incapacitated
* History of a clinically significant psychiatric disorder over the last year
* Has rapidly fluctuating renal function or has demonstrated or suspected renal artery stenosis
* Has had a kidney transplant
* Unstable endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
* History of cancer (Some exceptions apply)
* Regular user of barbiturates or sleep aides
* Consumes excessive amounts of alcohol (\>2 drinks/day)
* Consumes excessive amounts of caffeinated beverages (\>6/day)
* Has had major surgery within 4 weeks
* Has a history of significant multiple and/or severe allergies
* Has a history of cataplexy
* Participant works a night shift and is not able to avoid night shift work during the study
* Current or history of illicit drug abuse
* Nursing mothers
Healthy Participants:
* Is mentally or legally incapacitated;
* Has a history of stroke, chronic seizures, or major neurological disorder
* Unstable endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
* History of cancer (Some exceptions apply)
* Regular user of barbiturates or sleep aides
* Consumes excessive amounts of alcohol (\>2 drinks/day)
* Consumes excessive amounts of caffeinated beverages (\>6/day)
* Has had major surgery within 4 weeks
* Has a history of significant multiple and/or severe allergies
* Has a history of cataplexy
* Participant works a night shift and is not able to avoid night shift work during the study
* Current or history of illicit drug abuse
* Nursing mothers
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01059851
Study Brief:
Protocol Section:
NCT01059851