Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Study to Find Out How YM150 is Absorbed Into and Eliminated From the Body in Healthy Male Subjects

24. juni 2013 opdateret af: Astellas Pharma Europe B.V.

An Open Label Study to Evaluate the Pharmacokinetics of YM150 After a Single Oral Dose of C14-labeled YM150 in Healthy Male Subjects

The study aims to observe how YM150 was absorbed, distributed and excreted after dosing with a radio labeled drinking solution.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

Healthy male subjects are admitted on Day 0. Subjects receive a single oral dose of 14C-labeled YM150 in the morning of Day 1 and remain in the unit for 7 days (6 nights). Blood, plasma, urine and feces samples are collected until 120 hrs after dosing for analysis of 14C-labeled radioactivity, YM150, YM-222714 and other metabolites. Expired air is collected as well for assessment of 14C-radioactivity.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

6

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Zuidlaren, Holland, 9471 GP
        • PRA International EDS NL

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • Body weight between 60 and 100 kg and Body Mass Index between 18 and 30 kg/m2

Exclusion Criteria:

  • Known or suspected hypersensitivity to YM150 or any of the constituents of the formulations used
  • History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia, including but not limited to neutropenia, thrombocytopenia, thrombocytopathy, thromboasthenia, hemophilia, Von Willebrand's disease, and vascular purpura, bleeding gums or frequent nose bleeding
  • Family history of congenital vascular malformation (e.g. Marfan's Syndrome) and/or bleeding disorder (e.g. hemophilia, Von Willebrand's disease, Christmas disease)
  • History of peptic ulcer or of any other organic lesion susceptible to bleeding
  • Prothrombin time (PT) or Activated partial thromboplastin time (aPTT) at the screening visit outside the normal range
  • Any surgical intervention (including tooth extraction) or trauma within the last 3 months preceding the start of the study
  • Any clinically significant history of asthma, eczema, any other clinically significant allergic condition or previous severe hypersensitivity to any other drug
  • Any clinically significant upper gastro-intestinal symptoms likely to interfere with the absorption of the drug
  • History or presence of any cardiovascular disease or disorder
  • History of a clinically significant ECG abnormality
  • Any clinically relevant history of other disease or disorder - gastrointestinal, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic
  • Any clinically significant abnormality following the Investigator's review of the pre-study physical examination, ECG, and clinical laboratory tests
  • Abnormal heart rate and blood pressure measurements at the screening visit as follows: heart rate <40 or >90 bpm; mean systolic blood pressure <95 or >160 mmHg; mean diastolic blood pressure <40 or >95 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min)
  • Regular use of any prescribed or OTC drugs (including vitamins and herbal remedies) in the 4 weeks prior to admission to the clinical unit OR any use of such drugs in the 2 weeks prior to admission to the clinical unit
  • History of drug abuse at any time, OR any use of drugs of abuse within 3 months prior to admission to the clinical unit
  • Participation in any clinical study within 3 months, or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study
  • History of drinking more than 21 units of alcohol per week (1 unit = 270 ml of beer or 40 ml of spirits or 125 ml of wine) within 3 months prior to admission to the clinical unit
  • History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit
  • Subject, who is anti-HAV (IgM), anti-HCV, HBsAg or HIV-1 or -2 positive
  • Donation of blood (>400 ml) or blood products within 3 months prior to admission to the clinical unit or plasmapheresis within 4 weeks prior to admission to the clinical unit
  • Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a clinical study in the previous year

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment arm 1
14C-labeled YM150, oral solution
Andre navne:
  • darexaban

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pharmacokinetics of 14C-labeled YM150 assessed by whole blood, plasma, urine, feces and expired air concentrations
Tidsramme: Day 1 - Day 6
AUCinf (Amount excreted in urine extrapolated until infinity), AUClast (Amount excreted in urine until last sample), Cmax (Maximum concentration), tmax (Time to attain maximum concentration), tlag (Absorption lag time) and t1/2 (Apparent terminal elimination half-life). Excretion rate and cumulative excretion of radioactivity in urine, feces and expired air.
Day 1 - Day 6
Pharmacokinetics of YM150 and metabolites assessed by plasma and urine concentrations
Tidsramme: Day 1 - Day 6
- AUCinf, AUClast, Cmax, tmax, tlag and t1/2. In urine - amount excreted in urine, CLR (Renal clearance) and % of dose excreted.
Day 1 - Day 6

Sekundære resultatmål

Resultatmål
Tidsramme
Identification of the metabolic profile of YM150 in human plasma, urine and feces
Tidsramme: 0 - 2 hours Day 1
0 - 2 hours Day 1
Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events
Tidsramme: Day 1 - 14
Day 1 - 14

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2007

Primær færdiggørelse (Faktiske)

1. marts 2007

Studieafslutning (Faktiske)

1. marts 2007

Datoer for studieregistrering

Først indsendt

10. juli 2012

Først indsendt, der opfyldte QC-kriterier

1. august 2012

Først opslået (Skøn)

6. august 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2013

Sidst verificeret

1. august 2012

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 150-CL-015
  • 2006-001968-22 (EudraCT nummer)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Sunde mandlige emner

Kliniske forsøg med YM150

Abonner