- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02211937
Relative Oral Bioavailability of BI 44847 as Suspension Compared to Tablet and the Influence of Food Anf of BI 44847 as Solution Compared to Tablet in Healthy Male Volunteers
7. august 2014 opdateret af: Boehringer Ingelheim
Relative Oral Bioavailability of 400 mg BI 44847 as Suspension Compared to 400 mg BI 44847 as Tablet and the Influence of Food (Standardised High Fat Breakfast) on the Tablet in a Single Dose, Open-label, Randomised Three-way Crossover Trial and Relative Oral Bioavailability of 40 mg BI 44847 as Solution Compared to 40 mg BI 44847 as Tablet in Healthy Male Volunteers in a Single Dose, Open-label, Randomised Two-way Crossover Trial
Study to investigate the relative oral bioavailability of 400 mg BI 44847 as suspension vs. 400 mg BI 44847 as tablet, to investigate a food effect on the 400 mg tablet pharmacokinetic (PK) and to investigate relative oral bioavailability of 40 mg BI 44847 as solution vs. 40 mg BI 44847 as tablet.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
25
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 according to the following criteria based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Age ≥ 21 and Age ≤ 50 years
- BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Exclusion Criteria:
- Any finding of the medical examination (including BP, PR and 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
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- 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 based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months 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 trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of study centre
- Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval > 120 ms. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 450 ms or QT> 500 ms)
- A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- The use of concomitant medications that prolong the QT/QTc interval
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 |
---|---|
Aktiv komparator: Treatment A
BI 44847 suspension high dose, fasted
|
|
Eksperimentel: Treatment B
BI 44847 tablet high dose, fasted
|
|
Eksperimentel: Treatment C
BI 44847 tablet high dose, fed
|
|
Aktiv komparator: Treatment D
BI 44847 solution low dose, fasted
|
|
Eksperimentel: Treatment E
BI 44847 tablet low dose, fasted
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
AUC0-∞ (areal under koncentration-tid-kurven for analytten i plasma over tidsintervallet fra 0 ekstrapoleret til uendeligt)
Tidsramme: op til 48 timer efter lægemiddeladministration
|
op til 48 timer efter lægemiddeladministration
|
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Tidsramme: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
Cmax (maximum concentration of the analyte in plasma)
Tidsramme: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Vurdering af tolerabilitet af investigator på en 4-trins skala
Tidsramme: dag 3
|
dag 3
|
λz (terminalhastighedskonstant i plasma)
Tidsramme: op til 48 timer efter lægemiddeladministration
|
op til 48 timer efter lægemiddeladministration
|
t1/2 (terminal halveringstid af analytten i plasma)
Tidsramme: op til 48 timer efter lægemiddeladministration
|
op til 48 timer efter lægemiddeladministration
|
Vz/F (tilsyneladende distributionsvolumen under den terminale fase λz efter en ekstravaskulær dosis)
Tidsramme: op til 48 timer efter lægemiddeladministration
|
op til 48 timer efter lægemiddeladministration
|
fet1-t2 (fraktion af analyt elimineret i urinen fra tidspunkt t1 til tidspunkt t2)
Tidsramme: op til 48 timer efter lægemiddeladministration
|
op til 48 timer efter lægemiddeladministration
|
CLR,t1-t2 (renal clearance af analytten fra tidspunktet t1 til tidspunktet t2)
Tidsramme: op til 48 timer efter lægemiddeladministration
|
op til 48 timer efter lægemiddeladministration
|
%AUCtz-∞ (procentdelen af AUC0-∞, der opnås ved ekstrapolation)
Tidsramme: op til 48 timer efter lægemiddeladministration
|
op til 48 timer efter lægemiddeladministration
|
tmax (time from dosing to maximum concentration)
Tidsramme: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
MRTpo (mean residence time of the analyte in the body after po administration)
Tidsramme: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
CL/F (total clearance of the analyte in the plasma after extravascular administration)
Tidsramme: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Tidsramme: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
Number of patients with clinically relevant changes in vital signs
Tidsramme: up to 3 days after last drug administration
|
up to 3 days after last drug administration
|
Number of patients with clinically relevant findings in 12-lead electrocardiogram (ECG)
Tidsramme: up to 3 days after last drug administration
|
up to 3 days after last drug administration
|
Number of patients with adverse events
Tidsramme: up to 3 days after last drug administration
|
up to 3 days after last drug administration
|
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. januar 2007
Primær færdiggørelse (Faktiske)
1. marts 2007
Datoer for studieregistrering
Først indsendt
7. august 2014
Først indsendt, der opfyldte QC-kriterier
7. august 2014
Først opslået (Skøn)
8. august 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. august 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. august 2014
Sidst verificeret
1. august 2014
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1224.2
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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