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A Study of Effect of Food on the Pharmacokinetics of a Single JNJ-39823277 (TPI-1062) Dose in Healthy Participants

24. juni 2014 opdateret af: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Randomized, Open-Label, Two-Way Crossover Study to Determine the Effect of Food on the Pharmacokinetics of a Single JNJ-39823277 (TPI-1062) Dose in Healthy Male and Female Subjects

The purpose of this study is to evaluate the effect of food on the bioavailability of a single oral dose of JNJ-39823277 and its active metabolites.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), single-center, 2 treatment-sequence, and crossover study (method used to switch participants from one treatment arm to another in a clinical study). The study consist of 3 phases: a screening phase (within 21 days before medication administration), a 2-period open-label treatment phase, during which each participant will receive 1 of 2 open-label treatment sequences, and the end-of-study or withdrawal assessments (within 7-11 days after the last dose of the study medication). Participants will be randomly assigned to 1 of 2 treatment-sequences: Treatment Sequence AB (dosing in fed [with high fat diet] condition followed by dosing in fasted [without food] condition) or Treatment Sequence BA (dosing in fasted condition followed by dosing in fed condition). Study medication administrations will be separated by a washout period (period when receiving no treatment) of 7 to 14 days. The study duration for each participant will be approximately 6 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

32

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Participant must be a healthy male or non-lactating healthy female
  • Agrees to protocol-defined use of effective contraception
  • If a woman, must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening and on Day -1 of each treatment period
  • Agree to abstain from all medication (except for allowed birth control), including prescription and non-prescription (including vitamins and natural or herbal remedies)

Exclusion Criteria:

  • A history of clinically significant gastrointestinal, especially peptic ulcerations, gastrointestinal bleeding, ulcerative colitis, Crohn's disease or Irritable Bowel Syndrome, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, especially those with a past history of depression, suicidal ideation or suicidal attempts, or cardiovascular disease
  • Acute diarrhea or constipation in the 7 days before the predicted first study day. If screen occurs >7 days before first study day, this criterion will be determined on Day -1
  • Participant has donated blood within 90 days or plasma within 30 days of study dosing
  • Participant has used any over-the-counter or prescription medication, including vitamins, within 14 days prior to the study with the exception of acetaminophen
  • Participant has consumed products containing grapefruit juice or grapefruit, Seville oranges (eg, orange marmalade), quinine (eg, tonic water), or xanthine (eg, chocolate, caffeine containing products) within 24 hours (72 hours in the case of grapefruit juice and Seville oranges) prior to start of study drug administration

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: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment A
Participants will receive 100 mg JNJ-39823277 under fed (after a high fat) condition.
Medicin: JNJ-39823277
Participants will receive 100 mg of JNJ-39823277 tablet orally (by mouth) as a single dose.
Andre navne:
  • TPI-1062
Eksperimentel: Treatment B
Participants will receive 100 mg JNJ-39823277 under fasted condition.
Medicin: JNJ-39823277
Participants will receive 100 mg of JNJ-39823277 tablet orally (by mouth) as a single dose.
Andre navne:
  • TPI-1062

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Observed Plasma Concentration (Cmax) of JNJ-39823277
Tidsramme: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The Cmax is defined as maximum observed analyte concentration.
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-39823277
Tidsramme: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of JNJ-39823277
Tidsramme: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-39823277
Tidsramme: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 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.
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Elimination Half-Life Period (T1/2) of JNJ-39823277
Tidsramme: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The T1/2 is the time measured for the plasma concentration to decrease by 1 half to 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).
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of JNJ-40917006 (MC5 metabolite)
Tidsramme: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The Cmax is defined as maximum observed analyte concentration.
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-40917006 (MC5 metabolite)
Tidsramme: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of JNJ-40917006 (MC5 metabolite)
Tidsramme: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-40917006 (MC5 metabolite)
Tidsramme: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 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.
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Elimination Half-Life Period (T1/2) of JNJ-40917006 (MC5 metabolite)
Tidsramme: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The T1/2 is the time measured for the plasma concentration to decrease by 1 half to 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).
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Efterforskere

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

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. maj 2009

Primær færdiggørelse (Faktiske)

1. juni 2009

Studieafslutning (Faktiske)

1. juni 2009

Datoer for studieregistrering

Først indsendt

1. april 2014

Først indsendt, der opfyldte QC-kriterier

1. april 2014

Først opslået (Skøn)

4. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CR015718
  • TPI1062DEP1004 (Anden identifikator: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)

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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