- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02198352
Study to Determine Tolerability After Intravenous Administration of BIBN 4096 BS in Healthy Male and Female Volunteers
28. juli 2014 opdateret af: Boehringer Ingelheim
A Double-blind, Placebo-controlled Single Rising Dose Tolerability Study (Parallel Groups) in Healthy Male and Female Volunteers After Intravenous Administration of BIBN 4096 BS (Dosage: 0.1 - 10 mg)
The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single intravenous administration of increasing doses in healthy male and female volunteers
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
55
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
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Participants should be healthy males and females
- Age range from 21 to 50 years
- Within +- 20% of their normal weight (Broca-Index)
- All female volunteers must use a safe contraception (i.e. oral contraceptive, spiral; sterilized) and must have a negative pregnancy test
- In accordance with Good Clinical Practice (GCP) and local legislation each volunteers are supposed to give their written informed consent prior to admission to the study
- Each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead Electrocardiogram (ECG) within 14 days before the first administration of the test substance.
- Haematopoietic, hepatic and renal function test will be carried out in the laboratory
- The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations
Exclusion Criteria:
- Volunteers will be excluded from the study if the results of the medical examination or laboratory tests (especially those which indicate liver malfunction) are judged by the clinical investigator to differ significantly from normal clinical values
- Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of a drug with a long half-life (>= 24 hours) within ten half-lives of the respective drug before enrolment in the study
- Use of any other drugs which might influence the results of the trial during the week previous to the start of the study
- Participation in another study with an investigational drug within the last two months preceding this study
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on study days
- Alcohol abuse (> 40g/day)
- Drug abuse
- Blood donation ( >= 100 ml) within the last 4 weeks
- Excessive physical activities (e.g. competitive sports) within the last week before the study
- Pregnant and/or lactating volunteers
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 |
---|---|
Placebo komparator: Placebo
|
|
Eksperimentel: BIBN 4096 BS - i enkelt stigende doser
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Antal forsøgspersoner med uønskede hændelser
Tidsramme: op til 2 måneder
|
op til 2 måneder
|
Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate, respiratory rate)
Tidsramme: up to 8 days after last study day
|
up to 8 days after last study day
|
Number of subjects with abnormal changes in laboratory parameters
Tidsramme: up to 8 days after last study day
|
up to 8 days after last study day
|
Number of subjects with clinically relevant changes in venous-occlusion plethysmography
Tidsramme: up to 8 hours after drug administration
|
up to 8 hours after drug administration
|
Number of subjects with clinically significant changes in ECG (Electrocardiogram)
Tidsramme: up to 8 days after last study day
|
up to 8 days after last study day
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
AUC0-∞ (Areal under koncentration-tid-kurven for analytten i plasma over tidsintervallet fra 0 ekstrapoleret til uendeligt)
Tidsramme: op til 24 timer efter lægemiddeladministration
|
op til 24 timer efter lægemiddeladministration
|
Cmax (maksimal målt koncentration af analytten i plasma)
Tidsramme: op til 24 timer efter lægemiddeladministration
|
op til 24 timer efter lægemiddeladministration
|
t½ (Terminal halveringstid af analytten i plasma)
Tidsramme: op til 24 timer efter lægemiddeladministration
|
op til 24 timer efter lægemiddeladministration
|
MRT (Mean residence time of the analyte in the body)
Tidsramme: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
CL (Total clearance of the analyte in plasma following extravascular administration)
Tidsramme: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Vz (Apparent volume of distribution during the terminal elimination phase)
Tidsramme: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Vss (Volume of distribution at steady state)
Tidsramme: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Percentage of urinary excretion of BIBN 4096 BS
Tidsramme: up to 24 hours after drug administration
|
up to 24 hours after 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. juni 1998
Primær færdiggørelse (Faktiske)
1. august 1998
Datoer for studieregistrering
Først indsendt
22. juli 2014
Først indsendt, der opfyldte QC-kriterier
22. juli 2014
Først opslået (Skøn)
23. juli 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. juli 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juli 2014
Sidst verificeret
1. juli 2014
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1149.1
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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