- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02046798
A Study to Assess the Pharmacokinetics, Metabolism and Excretion Routes of ASP3652 in Man, After Administration of 14C Radio Labeled ASP3652
An Open Label Study to Evaluate the Pharmacokinetics of ASP3652 After a Single Oral Dose of 14C-labeled ASP3652 in Healthy Caucasian Male Subjects
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is an open-label, one-period, single-dose study with 14C labeled ASP3652.
Screening takes place between Day 22 to Day 2, and subjects are admitted to the clinic on Day -1.
On the morning of Day 1, each subject receives a single oral dose of 14C-labeled ASP3652. Blood, urine and feces samples for analysis of 14C radioactivity are collected until at least 120 h after dosing. Blood samples for the analysis of ASP3652 and metabolites are collected until 120 h after dosing.
The subjects remain in the clinic until Day 6 (or up to Day 13 in case discharge criteria are not met on Day 6) and return for an End of Study Visit (ESV) 7 to 14 days after (early) discharge.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Leeds, Det Forenede Kongerige, LS2 9LH
- Covance Clinical Research Unit (CRU) Ltd.
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Subject is white and of Caucasian origin.
- Regular defecation pattern (minimum once per day).
- Subject must agree to use a condom during sexual intercourse until 3 months after dosing. In addition to using a condom, subjects must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy.
Exclusion Criteria:
- Known or suspected hypersensitivity to ASP3652 or any components of the formulation used.
- Donation of blood or blood products within 3 months 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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 14C labeled ASP3652
|
mundtlig
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Total radioactivity in plasma
Tidsramme: Days 1 to 6 and up to Day 9
|
area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf), area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast), maximum concentration (Cmax), time to attain Cmax (tmax), apparent terminal elimination half-life (t½)
|
Days 1 to 6 and up to Day 9
|
Total radioactivity in whole blood
Tidsramme: Days 1 to 6 and up to Day 9
|
area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf), area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast), maximum concentration (Cmax), time to attain Cmax (tmax), apparent terminal elimination half-life (t½)
|
Days 1 to 6 and up to Day 9
|
Radioactivity ratio of plasma / blood
Tidsramme: Days 1 to 6 and up to Day 9
|
ratio concentrations per time point and AUC
|
Days 1 to 6 and up to Day 9
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Radioactivity excretion in urine
Tidsramme: Urine: Days 1-6 and up to Day 25
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excretion rate and cumulative excretion
|
Urine: Days 1-6 and up to Day 25
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Radioactivity excretion in feces
Tidsramme: Days 1-6 and up to Day 25
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excretion rate and cumulative excretion
|
Days 1-6 and up to Day 25
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Radioactivity excretion in urine and feces
Tidsramme: Urine: Days 1-6 and up to Day 25
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excretion rate and cumulative excretion
|
Urine: Days 1-6 and up to Day 25
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ASP3652 in plasma
Tidsramme: Days 1 to 6 and up to Day 9
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AUCinf, AUClast, Cmax, tmax, t1/2, apparent clearance after oral administration at steady state (CL/F), volume of terminal phase distribution at steady state (Vz/F)
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Days 1 to 6 and up to Day 9
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ASP3652 in urine
Tidsramme: Days 1-6 and up to Day 25
|
cumulative amount of unchanged drug excreted into the urine from time zero to infinity after single dose (Aeinf), cumulative amount of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast), renal clearance of the drug from plasma (CLR), percentage of unchanged drug excreted into the urine from time zero to infinity after single dose % of dose excreted (Aeinf%), percentage of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast%)
|
Days 1-6 and up to Day 25
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Ratio ASP3652 to 14C-radioactivity for AUCinf
Tidsramme: Days 1 to 6 and up to Day 9
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area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf)
|
Days 1 to 6 and up to Day 9
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Safety and tolerability after a single dose
Tidsramme: Screening (Day 22 to Day 2) to End of Study Visit (7 to 14 days after (early) discharge)
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Vital signs, 12-lead ECG, safety laboratory tests, physical examination, occurrence of Adverse Events (AE)
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Screening (Day 22 to Day 2) to End of Study Visit (7 to 14 days after (early) discharge)
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 3652-CL-0003
- 2011-004526-10 (EudraCT nummer)
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Kliniske forsøg med ASP3652
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Astellas Pharma Europe B.V.AfsluttetSunde emner | Farmakokinetik af ASP3652 | Farmakodynamik af ASP3652Det Forenede Kongerige
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Astellas Pharma Europe B.V.AfsluttetSunde emner | Farmakokinetik | Farmakodynamik | Effekt af RaceDet Forenede Kongerige
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Astellas Pharma Europe B.V.AfsluttetSmerte | Urologiske sygdomme | Cystitis, Interstitiel | UrinblæresygdomBelgien, Tjekkiet, Danmark, Tyskland, Letland, Litauen, Holland, Polen, Portugal, Rumænien, Den Russiske Føderation, Spanien
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Astellas Pharma Europe B.V.AfsluttetSunde emner | Farmakokinetik af ASP3652 | Farmakodynamik af ASP3652Holland
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Astellas Pharma IncAfsluttetKronisk bækkensmerter syndrom | Kronisk abakteriel prostatitisTjekkiet, Tyskland, Letland, Litauen, Polen, Spanien
-
Astellas Pharma Europe B.V.AfsluttetSunde emner | Farmakokinetik | Farmakodynamik | SikkerhedHolland
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Astellas Pharma Europe B.V.AfsluttetSunde emner | Drug-Drug Interaction (DDI)Det Forenede Kongerige