Oral Mucosal Absorption Study of Bicalutamide New Formulation
12. august 2011 opdateret af: AstraZeneca
Oral Mucosal Absorption Study of ICI176,334-1 (Bicalutamide New Formulation) in Japanese Healthy Male Subjects
The purpose of this study is to investigate the presence or absence of oral mucosal absorption of bicalutamide after ICI176,334.1 is given to Japanese healthy male subjects
Studieoversigt
Detaljeret beskrivelse
Oral mucosal absorption study of ICI176,334-1 (Bicalutamide new formulation) in Japanese healthy male subjects
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
8
Fase
- Fase 1
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
20 år til 45 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Japanese healthy male subjects aged 20 to 45 years
- Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product
- Have a body mass index (BMI) between 17 and 27 kg/m2
- Eligible based on the physical findings, supine BP, pulse rate, ECG and laboratory assessments, as judged by the investigator(s)
Exclusion Criteria:
- Presence of any disease under medical treatment
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunological, blood, endocrine, neurological or mental disease to interfere with absorption, distribution, metabolism or excretion of drugs judged by investigator(s)
- Presence of any infectious disease, such as bacteria, virus and fungus Presence of allergic disorder, such as asthma, pollen disease or atopic dermatitis, and judged as necessary any medical treatment
- Any large surgical history of gastrointestinal tract such as gastric/intestinal resection or suturation
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: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Active 1
8 subjects will receive ICI176,334-1
|
Forsøgspersonen vil modtage en enkelt dosis af ICI176,334-1
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in saliva.
Tidsramme: Blood samples are taken repeatedly for 72 hours and also taken at 168 hours after application of the investigational drug.
|
Blood samples are taken repeatedly for 72 hours and also taken at 168 hours after application of the investigational drug.
|
|
To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in plasma.
Tidsramme: Blood samples are taken repeatedly for 72 hours and also taken at 168 hours after application of the investigational drug.
|
Blood samples are taken repeatedly for 72 hours and also taken at 168 hours after application of the investigational drug.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To assess the safety by assessment of adverse event.
Tidsramme: Subjects will be monitored for adverse events prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.
|
Subjects will be monitored for adverse events prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.
|
|
To assess the safety by assessment of vital signs.
Tidsramme: Subjects will be monitored for vital signs prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.
|
Subjects will be monitored for vital signs prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.
|
|
To assess the safety by assessment of electrocardiograms (ECGs).
Tidsramme: Subjects will be monitored for electrocardiograms (ECGs) prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.
|
Subjects will be monitored for electrocardiograms (ECGs) prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. juli 2010
Primær færdiggørelse (Faktiske)
1. august 2010
Studieafslutning (Faktiske)
1. august 2010
Datoer for studieregistrering
Først indsendt
12. august 2011
Først indsendt, der opfyldte QC-kriterier
12. august 2011
Først opslået (Skøn)
15. august 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. august 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. august 2011
Sidst verificeret
1. august 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D6874L00016
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 .
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