- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02280018
A Safety, Tolerability and Pharmacokinetics Study of a Single Intravenous Dose of JNJ-49122944 in Healthy Male Participants
29. januar 2015 opdateret af: Janssen Research & Development, LLC
A Double Blind, Placebo-Controlled, Randomized Study to Investigate the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Dose of JNJ-49122944 in Healthy Male Subjects
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of JNJ-49122944 in healthy male participants after a single intravenous ([IV] within a vein) dose administration.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a double-blind (neither the researchers nor the participants know what treatment the participant is receiving), randomized (study drug assigned by chance), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), and single-center study.
The study will consist of Screening Period (2 to 21 days prior to participants' dose administration), Double-blind Treatment Period (single dose of JNJ-49122944 or placebo on Day 1), and Safety Follow-up Period (4 to 7 days after discharge).
The total duration of participation for each participant, including screening, will be up to approximately 4 weeks.
Blood samples will be collected for assessment of pharmacokinetic parameters.
Participants' safety will be monitored throughout the study.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Merksem, Belgien
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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
Han
Beskrivelse
Inclusion Criteria:
- Male participant, aged 18 to 55 inclusive
- Participant must have a body Mass Index (BMI) between 18 and 30 kilogram per square meter (kg/m^2), inclusive, and body weight not less than 50 kg
- Participant must be deemed healthy on the basis of physical examination, medical history, laboratory tests, vital signs, and 12-lead electrocardiogram within protocol-defined parameters performed at screening and Day -1
- Participant agrees to protocol-defined use of effective contraception
- Participant should be non-nicotine user for 6 months prior to screening
Exclusion Criteria:
- Participants with current or history of clinically significant medical illness
- Participants with history of drug or alcohol abuse within 5 years
- Routine consumption of greater than 450 milligram (mg) of caffeine per day by the participant
- Participants with recent vaccination or acute illness
- Blood donation or major blood loss within 3 months prior to study drug administration by the participant
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: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: JNJ-49122944, 5 milligram (mg)
Single dose of 5 mg JNJ-49122944, administered as a 22.2 milliliter (mL) intravenous (IV) infusion over 45 minutes in the morning following an overnight fast.
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Participants will receive single dose of 5 mg JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.
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Placebo komparator: Placebo
Placebo matched to JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes in the morning following an overnight fast.
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Participants will receive placebo matched to JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Tidsramme: Throughout the duration of study (up to 4 weeks)
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An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Throughout the duration of study (up to 4 weeks)
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Maximum Plasma Concentration (Cmax) of JNJ-49122944
Tidsramme: Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3
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The Cmax is the maximum observed plasma concentration during dosing interval.
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Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3
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Area Under the Plasma Concentration Time Curve From Time 0 to Last Quantifiable Time (AUClast) of JNJ-49122944
Tidsramme: Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3
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The AUC(last) is the area under the plasma concentration time curve from time 0 to the time corresponding to the last quantifiable plasma concentration.
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Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3
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Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-49122944
Tidsramme: Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3
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The AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
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Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3
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Percentage of Area Under the Plasma Concentration-time Curve Obtained by Extrapolation (%AUC [infinity,ex]) of JNJ-49122944
Tidsramme: Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3
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Percentage of area under the plasma concentration-time curve obtained by extrapolation (%AUC[inf,ex]) is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100 (AUC[0-infinity] - AUC[0-last])*100/AUC[0-infinity].
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Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3
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Elimination Half-life (t1/2) of JNJ-49122944
Tidsramme: Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3
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Elimination half-life (t [1/2]) is associated with the terminal slope (lambda [z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
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Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3
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Rate Constant (Lambda[z]) of JNJ-49122944
Tidsramme: Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3
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Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
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Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3
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Apparent Clearance (CL) of JNJ-49122944
Tidsramme: Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3
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Apparent clearance of JNJ-49122944 is calculated as Dose/AUC(infinity).
The AUC (infinity) is the area under the plasma concentration-time curve from time zero to infinite time.
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Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3
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Apparent Volume of Distribution (Vz) of JNJ-49122944
Tidsramme: Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3
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Apparent volume of distribution after intravenous administration is calculated as Dose divided by Lambda(z) multiplied by AUC(0-inifinity).
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Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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. november 2014
Primær færdiggørelse (Faktiske)
1. december 2014
Studieafslutning (Faktiske)
1. december 2014
Datoer for studieregistrering
Først indsendt
29. oktober 2014
Først indsendt, der opfyldte QC-kriterier
29. oktober 2014
Først opslået (Skøn)
31. oktober 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. januar 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. januar 2015
Sidst verificeret
1. januar 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- CR105925
- 49122944EDI1001 (Anden identifikator: Janssen Research & Development, LLC)
- 2014-002354-39 (EudraCT nummer)
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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