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A Study to Evaluate of the Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 in Healthy Male Participants

28. januar 2014 oppdatert av: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 (TPI 1062) After a Single Oral Dose in Healthy Male Subjects

The purpose of this study is to investigate the absorption, metabolic pathways and excretion of JNJ-39823277 in healthy male adults after administration of a single oral dose of a 25 mg (0.5 mg/mL solution) of 14C-JNJ-39823277.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is an open-label (all people know the identity of the intervention) and single-arm (group) study. The study consists of 3 phases including, the screening phase (within 3 weeks prior to the start of study medication), treatment phase (8 to 15 days), and the follow-up phase (up to 6 days after the discharge from the hospital). Approximately 6 participants will be receiving the 14C-JNJ-39823277 in the study. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The total duration of study will be up to approximately 6 weeks.

Studietype

Intervensjonell

Registrering (Faktiske)

6

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 56 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • Body mass index (BMI) between 20 and 30 kg/m2 (BMI will be calculated as weight [kg]/square of height [square meter])
  • Had consistent bowel movement habit (approximately once per day) within 30 days before dosing
  • No clinically significant laboratory and electrocardiogram abnormalities

Exclusion Criteria:

  • Exposure to radiation for professional or medical reasons (exception of dental x rays and plain chest x ray) within 1 year before study medication administration
  • History of or current clinically significant medical illness
  • Clinically significant abnormal laboratory values, physical examination
  • Positive test for drugs of abuse, such as cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, or barbiturates at screening and on the study medication administration

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 14C-JNJ-39823277
Legemiddel: 14C-JNJ-39823277
Participants will receive a single oral dose of 25 mg 14C-JNJ-39823277 as a 50-mL solution.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximum observed plasma concentration (Cmax) of 14C-JNJ-39823277 in plasma
Tidsramme: Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose
Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose
Time of observed maximum plasma concentration (Tmax) of 14C-JNJ-39823277
Tidsramme: Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of 14C-JNJ-39823277
Tidsramme: Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose
The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of 14C-JNJ-39823277
Tidsramme: Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose
Elimination Half-Life Period (T1/2) of 14C-JNJ-39823277
Tidsramme: Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose
T1/2 is the time measured for the plasma concentration to decrease by one-half of its original concentration. It is associated with the terminal rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose
Mass Balance After an Oral Dose of 14C-JNJ-39823277 as Generated From Recovery of Total Radioactivity Excreted in Urine and Feces
Tidsramme: Predose and up to 168 hours post-dose
Predose and up to 168 hours post-dose
Routes of 14C-JNJ-39823277 Elimination Measured Through Total Radioactivity Concentrations in Urine and Feces
Tidsramme: Predose and up to 168 hours post-dose
Predose and up to 168 hours post-dose
Whole Blood and Plasma Partitioning of Total Radioactivity Through Measurement of Total Radioactivity Levels in Blood
Tidsramme: Predose; post-dose 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours
Predose; post-dose 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours
Identification of Major Metabolites in Plasma, Urine, and Feces
Tidsramme: Predose and up to 168 hours post-dose
Predose and up to 168 hours post-dose

Sekundære resultatmål

Resultatmål
Tidsramme
Number of participants with adverse events as a measure of safety and tolerabilty
Tidsramme: Up to 6 weeks
Up to 6 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

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

Etterforskere

  • Studieleder: Johnson & Johnson Pharmaceutical Research & Development, L.L C.Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2009

Primær fullføring (Faktiske)

1. mai 2009

Studiet fullført (Faktiske)

1. mai 2009

Datoer for studieregistrering

Først innsendt

28. januar 2014

Først innsendt som oppfylte QC-kriteriene

28. januar 2014

Først lagt ut (Anslag)

30. januar 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

30. januar 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. januar 2014

Sist bekreftet

1. januar 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • CR100588
  • TPI1062DEP1005 (Annen identifikator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
  • 2009-010867-17 (EudraCT-nummer)

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