- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01638598
Single Rising Oral Doses of BI 1021958 in Healthy Chinese and Japanese Male Volunteers
31. oktober 2013 opdateret af: Boehringer Ingelheim
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1021958 in Healthy Chinese and Japanese Male Volunteers (Placebo-controlled, Randomised and Double-blind Within Dose Groups)
Safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1021958 after single rising doses (SRD) in healthy Asian male volunteers
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
80
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Seoul, Korea, Republikken
- 1310.3.8201 Boehringer Ingelheim Investigational Site
-
-
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
20 år til 45 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion criteria:
- Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
- Chinese ethnicity, Japanese ethnicity according to the following criteria Japanese; born in Japan, be a current Japanese passport holder, have lived outside of Japan <5 years, and have parents and grandparents who were all born in Japan Chinese; ethnic Chinese, born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China
- Age within the range of 20 to 45 years
- Body mass index within the range of 18.5 and 25 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Exclusion criteria:
- Any finding of the medical examination (including Blood Pressure, Pulse Rate, ECG and Safety laboratory) 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.
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy/hypersensitivity to the study drug or its excipients)
- Intake of drugs with a long half-life (more than 24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to administration
- Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval (based on the knowledge at the time of protocol preparation) within 10 days prior to administration
- Participation in another trial with an investigational drug administration within 2 months prior to administration
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 30 g/day)
- Drug abuse
- Blood donation (more than 100 mL within 4 weeks prior to administration)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval more than 450 ms), heart rate outside 45 to 90 bpm, or any other relevant ECG findings at screening
- A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of long QT Syndrome)
- Subjects considered unsuitable for inclusion by the investigator, e.g. because considered not able to understand and comply with study requirements, or have any condition which in the opinion of the investigator would not allow safe participation in the study
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 |
---|---|
Eksperimentel: BI 1021958 dose group 1
subject to receive a tablet containing dose group 1 BI 1021958 single dose
|
matching placebo in each dose level
BI 1021958
|
Eksperimentel: BI 1021958 dose group 2
subject to receive a tablet containing dose group 2 BI 1021958 single dose
|
matching placebo in each dose level
BI 1021958
|
Eksperimentel: BI 1021958 dose group 3
subject to receive a tablet containing dose group 3 BI 1021958 single dose
|
matching placebo in each dose level
BI 1021958
|
Eksperimentel: BI 1021958 dose group 4
subject to receive a tablet containing dose group 4 BI 1021958 single dose
|
matching placebo in each dose level
BI 1021958
|
Eksperimentel: BI 1021958 dose group 5
subject to receive a tablet containing dose group 5 BI 1021958 single dose
|
matching placebo in each dose level
BI 1021958
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The number (%) of subjects with related adverse events.
Tidsramme: up to 17 days postdose
|
up to 17 days postdose
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
AUC0-inf (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity)
Tidsramme: up to day 4 postdose
|
up to day 4 postdose
|
AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point)
Tidsramme: up to day 4 postdose
|
up to day 4 postdose
|
AUC0-12 (area under the concentration-time curve of BI 1021958 in plasma over the time interval from the time point 0 until the time point 12 h)
Tidsramme: up to day 4 postdose
|
up to day 4 postdose
|
Cmax (maximum measured concentration of BI 1021958 in plasma)
Tidsramme: up to day 4 postdose
|
up to day 4 postdose
|
AUC0-24 (area under the concentration-time curve of BI 1021958 in plasma over the time interval from the time point 0 until the time point 24 h)
Tidsramme: up to day 4 postdose
|
up to day 4 postdose
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. juli 2012
Primær færdiggørelse (Faktiske)
1. august 2012
Studieafslutning (Faktiske)
1. august 2012
Datoer for studieregistrering
Først indsendt
2. juli 2012
Først indsendt, der opfyldte QC-kriterier
11. juli 2012
Først opslået (Skøn)
12. juli 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. november 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. oktober 2013
Sidst verificeret
1. oktober 2013
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1310.3
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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-
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-
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-
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CSL BehringAfsluttetCrohns sygdomTyskland, Indien, Korea, Republikken, Taiwan, Forenede Stater, Hong Kong, Canada, Mexico, Østrig, Schweiz, Israel, Italien, Frankrig, Polen, Holland, Ungarn, Tjekkiet, Det Forenede Kongerige