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CompletedNCT01537757Updated Jan 26, 2015

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

A Phase 1 interventional study of MK-8931 in Alzheimer's Disease, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-26.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer's Disease
03

In context

Alzheimer Disease

3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's enrollment of 12 is below the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Part 1, Panel A - Severe Renal Impairment Group

    Drug: MK-8931

  • Experimental
    Part 1, Panel B - Healthy Control Group to Match Panel A

    Drug: MK-8931

  • Experimental
    Part 2, Panel C - Moderate Renal Impairment Group

    Drug: MK-8931

  • Experimental
    Part 2, Panel D - Healthy Control Group to Match Panel C

    Drug: MK-8931

  • Experimental
    Part 2, Panel E - Mild Renal Impairment Group

    Drug: MK-8931

  • Experimental
    Part 2, Panel F - Healthy Control Group to Match Panel E

    Drug: MK-8931

Interventions

  • DrugMK-8931

    Single dose, administered as oral capsules

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Renal clearance (CLr) of MK-8931

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

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

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01537757
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Feb 23, 2012
Start date
Mar 2012
Primary completion
May 2012
Completion
May 2012
Last update
Jan 26, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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