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 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT04303156
Eligibility Criteria:
Inclusion Criteria:
Healthy participants must have the following:
* Is in good health
* Has a body mass index (BMI) ≥18.5 and ≤40 kg/m2.
* Female is not pregnant or breastfeeding, and is not one of the following: a woman of childbearing potential (WOCBP); if a WOCBP, is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention
Renally impaired participants must have the following:
* With the exception of renal impairment, is in generally good health
* Has a BMI ≥ 18.5 and ≤ 40 kg/m2
* Female is not pregnant or breastfeeding, and is not one of the following: a woman of childbearing potential (WOCBP); if a WOCBP, is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention
Exclusion Criteria:
Healthy participants must have the following:
* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
* Is mentally or legally incapacitated, has significant emotional problems
* Has known hypersensitivity to the active substance or any of the excipients of the study drug
* Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food.
* Is positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.
* Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within prior 4 weeks
* Is taking medications to treat chronic medical conditions and/or conditions associated with renal disease
* Has participated in another investigational study within prior 4 weeks
Other exclusions for healthy participants:
* Does not agree to follow the smoking restrictions
* Consumes greater than 1 glass for women, or 2 glasses for men of alcoholic beverages per day
* Consumes excessive amounts,of caffeinated beverages per day.
* Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately prior 3 months.
Renally impaired participants must have the following:
* Has a history or presence of renal artery stenosis.
* Has had a renal transplant or nephrectomy.
* Has rapidly fluctuating renal function as determined by historical measurements.
* Has known hypersensitivity to the active substance or any of the excipients of the study drug.
* Has a history of cancer (malignancy).
* Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food.
* Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV).
* Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
* Is taking medications to treat chronic medical conditions and/or conditions associated with renal disease and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medication(s) within 4 hours prior to and 8 hours after administration of the study drug.
* Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit.
Other exclusions for renally impaired participants
* Does not agree to follow the smoking restrictions.
* Consumes greater than 1 glass for women, or 2 glasses for men of alcoholic beverages per day.
* Consumes excessive amounts of caffeinated beverages per day.
* Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04303156
Study Brief:
Protocol Section:
NCT04303156