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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT01537757
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index ≤39 kg/m\^2
* No clinically significant abnormality on electrocardiogram
* Female participant must be postmenopausal or surgically sterilized
* Non-vasectomized men must agree to use a condom with spermicide or abstain from sexual intercourse, during the trial and for 3 months after stopping the medication
Inclusion Criteria Specific to Renally Impaired Participants:
* Clinical diagnosis of renal insufficiency based on Estimated Glomerular Filtration rate (eGFR): severely decreased eGFR, defined as \<30 mL/min/1.73m\^2 and participant is not on dialysis; moderately decreased eGFR, defined as ≥30 to \<60 mL/min/1.73m\^2; mildly decreased eGFR, defined as ≥60 to \<80 mL/min/1.73m\^2
* Stable baseline health based on medical history, physical examination, vital signs, and laboratory tests
Inclusion Criterion Specific to Healthy Participants:
* eGFR ≥80 mL/min/1.73m\^2
Exclusion Criteria:
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug, including history or presence of inflammatory bowel disease, gastrointestinal or rectal bleeding; presence of active ulcer; history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; history of pancreatic injury or pancreatitis; history or presence of liver disease or liver injury; history of urinary obstruction or difficulty in voiding
* History of any infectious disease within 4 weeks prior to drug administration
* Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV) or human immunodeficiency virus (HIV)
* History of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of Long QT Syndrome)
* Participant has had a kidney removed or has a functioning renal transplant
* History of alcohol or drug abuse in the past 2 years
* Blood donation or loss of significant volume of blood in the past 60 days prior to dosing
* Previously received MK-8931
* History of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
* History of malignancy occurring within the 5 years immediately before screening, except for a participant who has been adequately treated for basal cell or squamous cell skin cancer; or in situ cervical cancer; or
localized prostate carcinoma; or has undergone potentially curative therapy with no evidence of recurrence ≥1 year post-therapy
Exclusion Criteria Specific to Renally Impaired Participants:
* Rapidly fluctuating renal function as determined by historical measurements
* Suspected renal artery stenosis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT01537757
Study Brief:
Protocol Section:
NCT01537757