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A Study to Evaluate the Mass Balance, Pharmacokinetics (PK), Metabolism and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Male Participants

31. května 2019 aktualizováno: Millennium Pharmaceuticals, Inc.

A Phase 1, Open-label, Single Intravenous Infusion Dose Study to Evaluate the Mass Balance, Pharmacokinetics, Metabolism, and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Adult Male Subjects

The purpose of this study is to determine the mass balance, routes of elimination and characterize the metabolic profiles of a single intravenous dose of [14C]-TAK-954, identify major circulating and excreted metabolites. This study will also determine the single-dose PK of total radioactivity, TAK-954 and its metabolites where possible.

Přehled studie

Postavení

Dokončeno

Intervence / Léčba

Detailní popis

The drug being tested in this study is called TAK-954. This study will assess the mass balance, metabolic profiles and routes of elimination of single intravenous dose of [14C]-TAK-954, and will determine the major circulating and excreted metabolites and single-dose PK of total radioactivity, TAK-954, THRX513466, and THRX 913682 in healthy male participants.

The study will enroll approximately 6 participants. All participants will receive a single dose of [14C]-TAK-954 0.5 mg on Day 1.

This single-center trial will be conducted in Netherlands. The overall time to participate in this study is approximately 6 to 7 weeks. Participants will make a final visit to the clinic 15 days after last dose of study drug for a follow-up assessment.

Typ studie

Intervenční

Zápis (Aktuální)

6

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Groningen, Holandsko, 9728 NZ
        • PRAHS

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 55 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Mužský

Popis

Inclusion Criteria:

  1. Be a man aged 18 to 55 years, inclusive, at the screening visit.
  2. Have a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 30 kilogram per square meter (kg/m^2) and a body weight greater than (>) 50 kilogram (kg) at the screening visit.
  3. Be a nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before administration of the initial dose of trial drug.
  4. Meet the following birth control requirements:

    • Is a male participant who is sterile or agrees to use an appropriate method of contraception, including a condom, from the first dose of study drug until 30 days after the last dose of study drug. No restrictions are required for a vasectomized male participant provided that the participant is at least 1 year postbilateral vasectomy procedure before the first dose of study drug. A male participant whose vasectomy procedure was performed less than 1 year before the first dose of study drug must follow the same restrictions as a nonvasectomized man. Appropriate documentation of surgical procedures should be provided.
    • Is a male participant who agrees to not donate sperm from trial drug administration on the first day of the first dose until 30 days after the last dose of study drug.

Exclusion Criteria:

  1. Has total 14C radioactivity measured by accelerator mass spectrometry in plasma (during screening) exceeding 14C/12C ratio 1.1E-12.
  2. Participated in any study with a radiation dose above 0.1 millibecquerel (MBq) or radiation burden above 0.1 millisievert (mSv) within 1 year before screening.
  3. Was exposed to significant radiation (example, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months before check-in.
  4. Irregular defecation pattern (less than once per 2 days).
  5. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to beer 354 milliliter [mL]/12 ounce [oz], wine 118 mL/4 oz, or distilled spirits 29.5 mL/1 oz).
  6. Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
  7. Has a substance abuse disorder.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: [14C]-TAK-954 0.5 mg
[14C]-TAK-954 0.5 milligram (mg), (containing approximately 1.5 microcurie [µCi] of radioactive tracer), administered as 60-minute infusion, intravenously, once on Day 1.
[14C]-TAK-954 intravenous infusion.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Cumulative Percentage of Administered Radioactivity Recovered in Urine
Časové okno: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Cumulative Percentage of Administered Radioactivity Recovered in Feces
Časové okno: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Cumulative Percentage of Radioactivity in Urine and Feces Combined
Časové okno: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined
Časové okno: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine
Časové okno: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Feces
Časové okno: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Mean Percent of Total Radioactivity in Plasma for TAK-954 and TAK-954 Metabolites
Časové okno: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Cumulative Percentage of Dose Excreted in Urine for TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Cumulative Percentage of Dose Excreted in Feces for TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
The cumulative percentage of dose excreted in feces as TAK-954 derived from 0-168 hour sampling was normalized for 100% recovery.
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Cmax: Maximum Observed Plasma and Whole Blood Concentrations of Radioactivity for [14C]-TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-954 and TAK-954 Metabolites
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUClast: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to the Time of the Last Quantifiable Radioactivity for [14C]-TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 and TAK-954 Metabolites
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUC∞: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to Infinity for [14C]-TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 and TAK-954 Metabolites
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity for [14C]-TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-954 and TAK-954 Metabolites
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
t1/2z: Terminal Disposition Phase Half-life of Radioactivity in Plasma and Whole Blood for [14C]-TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
t1/2z: Terminal Disposition Phase Half-life in Plasma for TAK-954 and TAK-954 Metabolites
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
CL: Total Clearance After Intravenous Administration for [14C]-TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
CL: Total Clearance of TAK-954 After Intravenous Administration of [14C]-TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for [14C]-TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Aet Urine: Amount of Total Radioactivity Excreted in Urine From Time 0 to Time t for [14C]-TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Aet Urine: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Aet Feces: Amount of Total Radioactivity Excreted in Feces From Time 0 to Time t for [14C]-TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Fet Urine: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Fet Urine: Fraction of Total Radioactivity Excreted in Urine From Time 0 to Time t for [14C]-TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Fet Feces: Fraction of Radioactivity Excreted in Feces From Time 0 to Time t for [14C]-TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Sekundární výstupní opatření

Měření výsledku
Časové okno
Ratio of Total Radioactivity in Whole Blood to Plasma
Časové okno: Day 1 pre-dose and at multiple time points (up to 264 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 264 hours) post-dose
Ratio of AUC∞: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 to Total Radioactivity in Plasma TAK-954
Časové okno: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)
Časové okno: Baseline up to Day 31
Baseline up to Day 31
Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation of [14C]-TAK-954
Časové okno: Baseline up to Day 15
Baseline up to Day 15

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

30. dubna 2018

Primární dokončení (Aktuální)

1. června 2018

Dokončení studie (Aktuální)

1. června 2018

Termíny zápisu do studia

První předloženo

9. dubna 2018

První předloženo, které splnilo kritéria kontroly kvality

9. dubna 2018

První zveřejněno (Aktuální)

18. dubna 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. července 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

31. května 2019

Naposledy ověřeno

1. května 2019

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • TAK-954-1005
  • U1111-1202-5762 (Jiný identifikátor: WHO)
  • NL65503.056.18 (Identifikátor registru: NL)
  • 2018-001181-42 (Číslo EudraCT)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Zdraví dobrovolníci

Klinické studie na [14C]-TAK-954

3
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