- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03500224
A Study to Evaluate the Mass Balance, Pharmacokinetics (PK), Metabolism and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Male Participants
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
Přehled studie
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
Zápis (Aktuální)
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
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Groningen, Holandsko, 9728 NZ
- PRAHS
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Be a man aged 18 to 55 years, inclusive, at the screening visit.
- 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.
- 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.
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:
- Has total 14C radioactivity measured by accelerator mass spectrometry in plasma (during screening) exceeding 14C/12C ratio 1.1E-12.
- 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.
- 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.
- Irregular defecation pattern (less than once per 2 days).
- 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).
- 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.
- Has a substance abuse disorder.
Studijní plán
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 |
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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.
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[14C]-TAK-954 intravenous infusion.
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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
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Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
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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
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Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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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
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Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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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
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Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
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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
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The cumulative percentage of dose excreted in feces as TAK-954 derived from 0-168 hour sampling was normalized for 100% recovery.
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 264 hours) post-dose
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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
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Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
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Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)
Časové okno: Baseline up to Day 31
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Baseline up to Day 31
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Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation of [14C]-TAK-954
Časové okno: Baseline up to Day 15
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Baseline up to Day 15
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
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)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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 .
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