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

23 januari 2015 uppdaterad av: Merck Sharp & Dohme LLC

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

12

Fas

  • Fas 1

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

50 år till 85 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Part 1, Panel A - Severe Renal Impairment Group
Single dose, administered as oral capsules
Experimentell: Part 1, Panel B - Healthy Control Group to Match Panel A
Single dose, administered as oral capsules
Experimentell: Part 2, Panel C - Moderate Renal Impairment Group
Single dose, administered as oral capsules
Experimentell: Part 2, Panel D - Healthy Control Group to Match Panel C
Single dose, administered as oral capsules
Experimentell: Part 2, Panel E - Mild Renal Impairment Group
Single dose, administered as oral capsules
Experimentell: Part 2, Panel F - Healthy Control Group to Match Panel E
Single dose, administered as oral capsules

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MK-8931
Tidsram: Predose through 120 hours post single dose of MK-8931
Predose through 120 hours post single dose of MK-8931

Sekundära resultatmått

Resultatmått
Tidsram
Renal clearance (CLr) of MK-8931
Tidsram: Predose through 120 hours post single dose of MK-8931
Predose through 120 hours post single dose of MK-8931
Fraction of MK-8931 dose excreted in urine (fe)
Tidsram: Predose through 120 hours post single dose of MK-8931
Predose through 120 hours post single dose of MK-8931

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2012

Primärt slutförande (Faktisk)

1 maj 2012

Avslutad studie (Faktisk)

1 maj 2012

Studieregistreringsdatum

Först inskickad

17 februari 2012

Först inskickad som uppfyllde QC-kriterierna

17 februari 2012

Första postat (Uppskatta)

23 februari 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

26 januari 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 januari 2015

Senast verifierad

1 januari 2015

Mer information

Termer relaterade till denna studie

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