- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02199873
Safety, Tolerability and Pharmacodynamics of BIIX 1 XX in Healthy Young Male Volunteers
28. oktober 2014 opdateret af: Boehringer Ingelheim
A Single Increasing Dose Safety, Tolerability and Pharmacodynamics (Methacholine Challenge) Study After Inhalational Administration of BIIX 1 XX (Single Doses: 5 - 800 mcg) in Healthy Young Male Volunteers (Randomised, Double-blind, Placebo-controlled)
The objective of the present study is to obtain information about the safety and tolerability of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a methacholine challenge test and to obtain preliminary pharmacokinetic data
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
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 male volunteers who have Broca-Indices within +-20%
- Participants in the age range between 21 to 50 years
- Following the methacholine challenge the airway resistance (Raw) shows an increase of at least 130%
- In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give his written informed consent prior to admission to the study
- As part of the screening (within 14 days before drug administration), each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/exclusion criteria and concomitant therapy) as well as a 12-lead Electrocardiogram (ECG)
- 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. The above mentioned examinations will be performed within 14 days before the first administration of the test substance
Exclusion Criteria:
- Volunteers will be excluded from the study if the results of the medical examination or laboratory tests 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 one month before enrolment in the study
- Use of any drugs which might influence the results of the trial 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 (> 60g/day)
- Drug abuse
- Blood donation within the last 4 weeks
- Excessive physical activities within the last week before 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: Enkelt gruppeopgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Placebo
|
|
Eksperimentel: BIIX 1 XX - single rising dose
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Antal forsøgspersoner med unormale ændringer i laboratorieparametre
Tidsramme: op til 8 dage efter sidste lægemiddeladministration
|
op til 8 dage efter sidste lægemiddeladministration
|
Number of subjects with adverse events
Tidsramme: up to 3 months
|
up to 3 months
|
Change in impedance cardiography
Tidsramme: up to 30 minutes after drug administration
|
up to 30 minutes after drug administration
|
Change in cutaneous microcirculation
Tidsramme: up to 30 minutes after drug administration
|
up to 30 minutes after drug administration
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in airway resistance (Raw) after methacholine challenge
Tidsramme: up to 30 minutes after drug administration
|
up to 30 minutes after drug administration
|
Change in specific conductance (sGaw) after methacholine challenge
Tidsramme: up to 30 minutes after drug administration
|
up to 30 minutes after drug administration
|
AUC (Area under the concentration-time curve of the analyte in plasma)
Tidsramme: up to 168 hours after drug administration
|
up to 168 hours after drug administration
|
Cmax (Maximum measured concentration of the analyte in plasma)
Tidsramme: up to 168 hours after drug administration
|
up to 168 hours after drug administration
|
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Tidsramme: up to 168 hours after drug administration
|
up to 168 hours after drug administration
|
Ae (Amount of analyte that is eliminated in urine)
Tidsramme: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
MRT (Mean residence time of the analyte in the body)
Tidsramme: up to 168 hours after drug administration
|
up to 168 hours after drug administration
|
t½ (Terminal half-life of the analyte in plasma)
Tidsramme: up to 168 hours after drug administration
|
up to 168 hours after drug administration
|
CL/F(Apparent clearance of the analyte in plasma following extravascular administration)
Tidsramme: up to 168 hours after drug administration
|
up to 168 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. september 1998
Datoer for studieregistrering
Først indsendt
24. juli 2014
Først indsendt, der opfyldte QC-kriterier
24. juli 2014
Først opslået (Skøn)
25. juli 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. oktober 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. oktober 2014
Sidst verificeret
1. oktober 2014
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1150.1
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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