- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02183662
Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW in Healthy Male Volunteers.
7. juli 2014 opdateret af: Boehringer Ingelheim
Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW at 6.2 mg, 12.5 mg, 25 mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg and 1200 mg Dose Levels in Healthy Male Volunteers (Randomized, Double-blind, Placebo-controlled Within Dose Groups)
To investigate safety and pharmacokinetics of BI 224436 ZW
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
105
Fase
- Fase 1
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
21 år til 50 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Healthy males
- Age ≥21 and Age ≤50 years
- Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation.
Exclusion Criteria:
- Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- HIV infection and other chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within one month prior to administration or during the trial
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the treatment period)
- Any laboratory value outside the reference range that is of clinical relevance
- A baseline prolongation of QT/QTc interval (e.g., a QTc interval ≥450 ms)
- A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Bradycardia (PR <60 beats/min)
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Placebo
|
|
Eksperimentel: BI 224436
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
maximum measured concentration of the analyte in plasma
Tidsramme: up to 72 hours
|
up to 72 hours
|
area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24
Tidsramme: up to 24 hours
|
up to 24 hours
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Tidsramme: up to 72 hours
|
up to 72 hours
|
minimum observed concentration at 24 hours
Tidsramme: up to 24 hours
|
up to 24 hours
|
terminal half-life of the analyte in plasma
Tidsramme: up to 72 hours
|
up to 72 hours
|
time from dosing to maximum measured concentration of the analyte in plasma
Tidsramme: up to 72 hours
|
up to 72 hours
|
apparent clearance of the analyte in plasma
Tidsramme: up to 72 hours
|
up to 72 hours
|
apparent volume of distribution during the terminal phase λz
Tidsramme: up to 72 hours
|
up to 72 hours
|
apparent volume of distribution
Tidsramme: up to 72 hours
|
up to 72 hours
|
mean residence time of the analyte in the body after single oral administration
Tidsramme: up to 72 hours
|
up to 72 hours
|
terminal rate constant in plasma
Tidsramme: up to 72 hours
|
up to 72 hours
|
the last measurable concentration in the concentration-time profile
Tidsramme: up to 72 hours
|
up to 72 hours
|
the extrapolated Area under the curve from the time of the last measurable concentration in the concentration-time profile to infinity
Tidsramme: up to 72 hours
|
up to 72 hours
|
the percentage of the Area under the concentration-time curve until infinity, that is determined by extrapolation
Tidsramme: up to 72 hours
|
up to 72 hours
|
amount of analyte that is eliminated in urine from the time point t0 to time point t4
Tidsramme: up to 4 hours
|
up to 4 hours
|
amount of analyte that is eliminated in urine from the time point t4 to time point t8
Tidsramme: from 4 to 8 hours
|
from 4 to 8 hours
|
amount of analyte that is eliminated in urine from the time point t8 to time point t12
Tidsramme: from 8 to 12 hours
|
from 8 to 12 hours
|
amount of analyte that is eliminated in urine from the time point t12 to time point t24
Tidsramme: from 12 to 24 hours
|
from 12 to 24 hours
|
fraction of analyte eliminated in urine from time point t0 to time point t24
Tidsramme: up to 24 hours
|
up to 24 hours
|
renal clearance of the analyte from the time point t0 until the time point t24
Tidsramme: up to 24 hours
|
up to 24 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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 2009
Primær færdiggørelse (Faktiske)
1. marts 2010
Datoer for studieregistrering
Først indsendt
7. juli 2014
Først indsendt, der opfyldte QC-kriterier
7. juli 2014
Først opslået (Skøn)
8. juli 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. juli 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. juli 2014
Sidst verificeret
1. juli 2014
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1277.1
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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