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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01537757
First received: February 17, 2012
Last updated: February 21, 2014
Last verified: February 2014

February 17, 2012
February 21, 2014
March 2012
May 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01537757 on ClinicalTrials.gov Archive Site
  • Renal clearance (CLr) of MK-8931 [ Time Frame: Predose through 120 hours post single dose of MK-8931 ] [ Designated as safety issue: No ]
  • Fraction of MK-8931 dose excreted in urine (fe) [ Time Frame: Predose through 120 hours post single dose of MK-8931 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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])

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
Drug: MK-8931
Single dose, administered as oral capsules
  • Experimental: Part 1, Panel A - Severe Renal Impairment Group
    Intervention: Drug: MK-8931
  • Experimental: Part 1, Panel B - Healthy Control Group to Match Panel A
    Intervention: Drug: MK-8931
  • Experimental: Part 2, Panel C - Moderate Renal Impairment Group
    Intervention: Drug: MK-8931
  • Experimental: Part 2, Panel D - Healthy Control Group to Match Panel C
    Intervention: Drug: MK-8931
  • Experimental: Part 2, Panel E - Mild Renal Impairment Group
    Intervention: Drug: MK-8931
  • Experimental: Part 2, Panel F - Healthy Control Group to Match Panel E
    Intervention: Drug: MK-8931
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
50 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01537757
P08535, MK-8931-009
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP