- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01537757
A Two-Part, Single-Dose Study of the Pharmacokinetics of MK-8931 in Subjects With Renal Insufficiency (MK-8931-009 [P08535])
23. januar 2015 oppdatert 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
12
Fase
- Fase 1
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Part 1, Panel A - Severe Renal Impairment Group
|
Single dose, administered as oral capsules
|
Eksperimentell: Part 1, Panel B - Healthy Control Group to Match Panel A
|
Single dose, administered as oral capsules
|
Eksperimentell: Part 2, Panel C - Moderate Renal Impairment Group
|
Single dose, administered as oral capsules
|
Eksperimentell: Part 2, Panel D - Healthy Control Group to Match Panel C
|
Single dose, administered as oral capsules
|
Eksperimentell: Part 2, Panel E - Mild Renal Impairment Group
|
Single dose, administered as oral capsules
|
Eksperimentell: Part 2, Panel F - Healthy Control Group to Match Panel E
|
Single dose, administered as oral capsules
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MK-8931
Tidsramme: Predose through 120 hours post single dose of MK-8931
|
Predose through 120 hours post single dose of MK-8931
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Renal clearance (CLr) of MK-8931
Tidsramme: 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)
Tidsramme: Predose through 120 hours post single dose of MK-8931
|
Predose through 120 hours post single dose of MK-8931
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2012
Primær fullføring (Faktiske)
1. mai 2012
Studiet fullført (Faktiske)
1. mai 2012
Datoer for studieregistrering
Først innsendt
17. februar 2012
Først innsendt som oppfylte QC-kriteriene
17. februar 2012
Først lagt ut (Anslag)
23. februar 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
26. januar 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. januar 2015
Sist bekreftet
1. januar 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P08535
- MK-8931-009 (Annen identifikator: Schering -Plough)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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