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A Study to Investigate the Absorption, Metabolism, and Excretion of Canagliflozin (JNJ-28431754) in Healthy Male Volunteers

28. juni 2016 opdateret af: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

An Open-Label Study to Investigate the Absorption, Metabolism, and Excretion of JNJ-28431754 in Healthy Male Subjects Following a Single Oral Dose Administration of 14C-JNJ-28431754

The purpose of this study is to investigate the absorption (the way the drug enters the body), metabolism (the way the drug is broken down in the body), and excretion (the way drug leaves the body) of canagliflozin (JNJ-28431754) in healthy male volunteers after a single dose of radiolabeled 14C-canagliflozin (14C-JNJ-28431754). The safety and tolerability of canagliflozin will also be assessed.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study will be an open label (all volunteers and study staff know the identity of the assigned treatment), single dose, single center study to investigate the absorption, metabolism, and excretion of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus). The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of study (or follow-up) phase. On Day 1, all volunteers will receive a single oral dose of radiolabeled 14C-canagliflozin which contains 196 mg of canagliflozin and approximately 40 microcurie (1480kBq) of radioactivity. The International Commission on Radiological Protection considers this amount of radioactivity to be acceptable for this type of study. The radioactivity allows the amount of canagliflozin and its metabolites (break-down products) to be more precisely measured in blood, plasma, urine, and feces samples, which will be collected from each volunteer. The total duration of the study is approximately 5 weeks (including screening and follow-up); this time will be increased by 6 days in volunteers who have a slower rate of excretion of canagliflozin.

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

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 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • Body Mass Index (BMI) (weight [kg]/height [m2]) between 18 and 30 kg/m2
  • Non-smoker

Exclusion Criteria:

  • Exposure to radiation for professional or medical reasons (except dental x-rays and x-rays of thorax and bone skeleton, excluding spinal column) in the past 12 months
  • History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Radiolabeled 14C-canagliflozin
Each volunteer will receive a single dose of radiolabelled 14C-canagliflozin (14C-JNJ-28431754) on Day 1.
Medicin: Radiolabelled 14C-canagliflozin (14C-JNJ-28431754)
A single oral dose of 196 mg radiolabeled 14C-canagliflozin (14C-JNJ-28431754) liquid suspension containing approximately 40 microcurie (1480 kBq) of 14C radioactivity will be administered on Day 1.
Andre navne:
  • 14C-JNJ-28431754

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plasma concentrations of canagliflozin (JNJ-28431754)
Tidsramme: Up to Day 3
Plasma concentrations of canagliflozin (JNJ-28431754) will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).
Up to Day 3
Urine concentrations of canagliflozin (JNJ-28431754)
Tidsramme: Up to Day 14
Urine concentrations of canagliflozin (JNJ-28431754) will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).
Up to Day 14
Total radioactivity of 14C-canagliflozin (14C-JNJ-28431754) excreted in urine
Tidsramme: up to Day 14
The total radioactivity excreted in the urine will be expressed as a percentage of the administered dose of canagliflozin (JNJ-28431754) and will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).
up to Day 14
Total radioactivity of 14C-canagliflozin (14C-JNJ-28431754) excreted in feces
Tidsramme: Up to Day 14
The total radioactivity excreted in the feces will be expressed as a percentage of the administered dose of canagliflozin (JNJ-28431754) and will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).
Up to Day 14
Total radioactivity of 14C-canagliflozin (14C-JNJ-28431754) in blood
Tidsramme: Up to Day 8
The total radioactivity in blood will be used to determine pharmacokinetic parameters for canagliflozin (JNJ-28431754) (measurements describing how the body affects the drug).
Up to Day 8
Total radioactivity of 14C-canagliflozin (14C-JNJ-28431754) in plasma
Tidsramme: Up to Day 8
The total radioactivity in plasma will be used to determine pharmacokinetic parameters for canagliflozin (JNJ-28431754) (measurements describing how the body affects the drug).
Up to Day 8
Concentrations of canagliflozin (JNJ-28431754) metabolites in plasma
Tidsramme: Up to Day 14
Concentrations of canagliflozin (JNJ-28431754) metabolites in plasma will be used to investigate the metabolism of canagliflozin (the way the drug is broken down in the body).
Up to Day 14
Concentrations of canagliflozin (JNJ-28431754) metabolites in urine
Tidsramme: Up to Day 14
Concentrations of canagliflozin (JNJ-28431754) metabolites in urine will be used to investigate the metabolism of canagliflozin (the way the drug is broken down in the body).
Up to Day 14
Concentrations of canagliflozin (JNJ-28431754) metabolites in feces
Tidsramme: Up to Day 14
Concentrations of canagliflozin (JNJ-28431754) metabolites in feces will be used to investigate the metabolism of canagliflozin (the way the drug is broken down in the body).
Up to Day 14

Sekundære resultatmål

Resultatmål
Tidsramme
Number of volunteers with adverse events as a measure of safety and tolerability
Tidsramme: up to 5 weeks
up to 5 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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. august 2007

Primær færdiggørelse (Faktiske)

1. september 2007

Studieafslutning (Faktiske)

1. oktober 2007

Datoer for studieregistrering

Først indsendt

12. februar 2013

Først indsendt, der opfyldte QC-kriterier

12. februar 2013

Først opslået (Skøn)

13. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR013624
  • 28431754NAP1006 (Anden identifikator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
  • 2007-004218-15 (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 Radiolabelled 14C-canagliflozin (14C-JNJ-28431754)

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