a two-part, single-dose study of the pharmacokinetics of mk-8931 in subjects with renal insufficiency (mk-8931-009 [p08535])

Conditions: Alzheimer's Disease

Summary: this study will assess the pharmacokinetics of mk-8931, a ß-secretase inhibitor, in participants with renal insufficiency. in part 1 of the study, pharmacokinetics of mk-8931 in participants with severe renal disease and in healthy matched control participants will be studied. if data from part 1 confirms that severe renal impairment does not alter the pharmacokinetics of mk-8931 to the extent requiring dosage adjustment, then no further study will be required and part 2 will be optional. if the data does not support this conclusion, then part 2 will be conducted to study the pharmacokinetics of mk-8931 in participants with moderate and mild renal impairment compared to healthy matched controls.


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