CompletedPhase 1

A Two-Part, Single-Dose Study of the Pharmacokinetics of MK-8931 in Subjects With Renal Insufficiency (MK-8931-009 [P08535])

An Open-Label, Two-Part, Single-Dose Study to Investigate the Pharmacokinetics of MK-8931 in Subjects With Renal Insufficiency (Protocol No. MK-8931-009 [P08535])

Lead sponsor

Merck Sharp & Dohme LLC

Asset

Verubecestat

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Healthy volunteers

Primary endpoint

•AUC

Identifiers

Registered as

Secondary IDMK-8931-009Schering -Plough

NCT IDNCT01537757

Org study IDP08535

Timeline

Milestones

Study first posted2012-02-23estimated

Study start2012-03 (month precision)

Primary completion2012-05actual (month precision)

Study completion2012-05actual (month precision)

Last update posted2015-01-26estimated

Assets

Drug assets

Verubecestat

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MK-8931

Time frame:Predose through 120 hours post single dose of MK-8931

concentration, descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Renal clearance (CLr) of MK-8931

Time frame:Predose through 120 hours post single dose of MK-8931

descriptive

Secondary/protocol endpoint/low confidence

Fraction of MK-8931 dose excreted in urine (fe)

Time frame:Predose through 120 hours post single dose of MK-8931

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.