A Two-Part, Single-Dose Study of the Pharmacokinetics of MK-8931 in Subjects With Renal Insufficiency (MK-8931-009 [P08535])
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01537757 |
Recruitment Status :
Completed
First Posted : February 23, 2012
Last Update Posted : January 26, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Drug: MK-8931 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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]) |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Part 1, Panel A - Severe Renal Impairment Group |
Drug: MK-8931
Single dose, administered as oral capsules |
Experimental: Part 1, Panel B - Healthy Control Group to Match Panel A |
Drug: MK-8931
Single dose, administered as oral capsules |
Experimental: Part 2, Panel C - Moderate Renal Impairment Group |
Drug: MK-8931
Single dose, administered as oral capsules |
Experimental: Part 2, Panel D - Healthy Control Group to Match Panel C |
Drug: MK-8931
Single dose, administered as oral capsules |
Experimental: Part 2, Panel E - Mild Renal Impairment Group |
Drug: MK-8931
Single dose, administered as oral capsules |
Experimental: Part 2, Panel F - Healthy Control Group to Match Panel E |
Drug: MK-8931
Single dose, administered as oral capsules |
- 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 ]
- Renal clearance (CLr) of MK-8931 [ Time Frame: Predose through 120 hours post single dose of MK-8931 ]
- Fraction of MK-8931 dose excreted in urine (fe) [ Time Frame: Predose through 120 hours post single dose of MK-8931 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT01537757 |
Other Study ID Numbers: |
P08535 MK-8931-009 ( Other Identifier: Schering -Plough ) |
First Posted: | February 23, 2012 Key Record Dates |
Last Update Posted: | January 26, 2015 |
Last Verified: | January 2015 |
Alzheimer Disease Renal Insufficiency Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases |
Neurocognitive Disorders Mental Disorders Kidney Diseases Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases |