- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02259946
Study to Investigate Safety and Tolerability of BI 1744 CL in Free Dose Combination With Tiotropium Bromide Both Administered by Respimat® in Healthy Male Volunteers
A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses (2.5 μg, 5 μg, 10 μg, 20 μg and 40 μg) of BI 1744 CL (Administered With the Respimat®) in Free Dose Combination With Tiotropium Bromide 5 μg ( for Doses up to and Including 20 μg BI 1744 CL), 10 μg (for Doses of 20 μg and 40 μg BI 1744 CL) (Administered With the Respimat®) in Healthy Male Volunteers
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG measurement, and clinical laboratory tests. Absence of any clinically relevant abnormality. Absence of any clinically relevant concomitant disease
- Age ≥21 and ≤50 years
- BMI ≥18.5 and <30 kg/m2 (Body Mass Index)
- 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 BP, PR, and ECG measurements) deviating from normal and of clinical relevance
- 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 the drug or its excipients) as judged clinically relevant by the investigator
- Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomization
- 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 enrolment in the study or during the study
- Participation in another trial with an investigational drug within 2 months prior to randomization
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days as judged by the investigator
- Alcohol abuse (regularly more than 40 g alcohol per day for men)
- Drug abuse
- Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
- Excessive physical activities within 1 week prior to randomization or during the trial
- Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of the study centre
Additionally, following exclusion criteria that are of particular relevance with regard to the known properties of BI 1744 CL as a ß-adrenoceptor agonist must be adhered to:
- Asthma or history of pulmonary hyperreactivity
- Hyperthyrosis
- Allergic rhinitis in need of treatment
- Clinically relevant cardiac arrhythmia
Paroxysmal tachycardia
Furthermore, the following exclusion criteria that are of particular relevance with regard to the known properties of tiotropium as an antimuscarinic anticholinergic agent must be adhered to:
- Hypersensitivity to tiotropium and/or related drugs of these classes
- History of narrow-angle glaucoma
- History of prostatic hyperplasia
- History of bladder-neck obstruction
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Placebo
|
|
Eksperimentell: BI 1744 CL - single rising dose + Tiotropium
Single rising dose of BI 1744 CL (conjointly with Tiotropium bromide)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Vurdering av tolerabilitet av utreder på en 4-punkts skala
Tidsramme: 12 dager etter legemiddeladministrering
|
12 dager etter legemiddeladministrering
|
|
Number of participants with abnormal findings in physical examination
Tidsramme: up to 12 days after drug administration
|
up to 12 days after drug administration
|
|
Number of participants with abnormal changes in laboratory parameters
Tidsramme: up to 12 days after drug administration
|
up to 12 days after drug administration
|
|
Number of participants with clinically significant changes in vital signs
Tidsramme: up to 12 days after drug administration
|
blood pressure (BP), pulse rate (PR), respiratory rate (RR)
|
up to 12 days after drug administration
|
Number of participants with adverse events
Tidsramme: up to 12 days after drug administration
|
up to 12 days after drug administration
|
|
Number of participants with clinically significant changes in 12-lead ECG
Tidsramme: up to 12 days after drug administration
|
cardiac axis, heart rate, PQ interval, QRS interval, uncorrected QT interval, HR-corrected QT-interval according to Bazett and Fridericia
|
up to 12 days after drug administration
|
Number of abnormal findings on oropharyngeal inspection
Tidsramme: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
|
Number of abnormal findings on pulmonary auscultation
Tidsramme: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
|
Change in Airway resistance (Raw)
Tidsramme: up to 24 hours after drug administration
|
measured by whole-body plethysmography
|
up to 24 hours after drug administration
|
Change in specific conductance (sGaw)
Tidsramme: up to 24 hours after drug administration
|
measured by whole-body plethysmography
|
up to 24 hours after drug administration
|
Change in Cyclic aminomonophosphate (cAMP)
Tidsramme: up to 6 hours after drug administration
|
up to 6 hours after drug administration
|
|
Change in potassium
Tidsramme: up to 6 hours after drug administration
|
up to 6 hours after drug administration
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
λz (terminalhastighetskonstant i plasma)
Tidsramme: opptil 96 timer etter administrering av legemidlet
|
opptil 96 timer etter administrering av legemidlet
|
Vz/F (tilsynelatende distribusjonsvolum under terminalfasen λz etter en ekstravaskulær dose)
Tidsramme: opptil 96 timer etter administrering av legemidlet
|
opptil 96 timer etter administrering av legemidlet
|
Cmax (maximum measured concentration of BI 1744 BS and tiotropium in plasma)
Tidsramme: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
tmax (time from dosing to maximum measured concentration)
Tidsramme: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
AUC0-∞ (area under the concentration-time curve of BI 1744 BS and tiotropium in plasma over the time interval from 0 extrapolated to infinity)
Tidsramme: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
AUC0-tz (area under the concentration-time curve of the analyte salmeterol in plasma over the time interval from 0 to the time of the last quantifiable data point)
Tidsramme: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
%AUCtz-∞ (percentage of the extrapolated part of the total AUC0-∞)
Tidsramme: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
t1/2 (terminal half-life of BI 1744 BS and tiotropium in plasma)
Tidsramme: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
MRTih (mean residence time of BI 1744 BS and tiotropium in the body after inhalation)
Tidsramme: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
CL/F (apparent clearance of BI 1744 BS and tiotropium in plasma after extravascular administration)
Tidsramme: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
Aet1-t2 (amount of BI 1744 BS and tiotropium eliminated in urine from the time point t1 to time point t2)
Tidsramme: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
fet1-t2 (fraction of BI 1744 BS and tiotropium eliminated in urine from time point t1 to time point t2)
Tidsramme: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
CLR,t1-t2 (renal clearance of BI 1744 BS and tiotropium from the time point t1 until the time point t2)
Tidsramme: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Parasympatholytika
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Kolinerge antagonister
- Kolinerge midler
- Antikonvulsiva
- Bronkodilatatorer
- Anti-astmatiske midler
- Luftveismidler
- Tiotropiumbromid
- Bromider
- Olodaterol
Andre studie-ID-numre
- 1237.1
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Sunn
-
Universidade do PortoFundação para a Ciência e a TecnologiaRekrutteringHealthy People-programmerPortugal
-
VA Office of Research and DevelopmentFullført
-
Universidad Católica del MauleFullført
-
University of MiamiJames and Esther King Biomedical Research ProgramAvsluttetHealthy Lifetime Ikke-røykereForente stater
-
Fundació Institut de Recerca de l'Hospital de la...FullførtHealthy People-programmerSpania
-
University of LeicesterNational Institute for Health Research, United KingdomFullførtPasienter med hjertesvikt og bevart ejeksjonsfraksjon - HFpEF | Pasienter med hjertesvikt med redusert ejeksjonsfraksjon - HFrEF | Healthy Controls Group - alders- og kjønnsmatchet
-
University Hospital, GrenobleUniversity Hospital, Clermont-Ferrand; Grenoble Institut des NeurosciencesAvsluttetParkinsons sykdom | Healthy Controls Group - alders- og kjønnsmatchetFrankrike
Kliniske studier på Placebo
-
SamA Pharmaceutical Co., LtdUkjentAkutt bronkitt | Akutt øvre luftveisinfeksjonKorea, Republikken
-
National Institute on Drug Abuse (NIDA)FullførtCannabisbrukForente stater
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyFullførtMannlige personer med type II diabetes (T2DM)Tyskland
-
Heptares Therapeutics LimitedFullførtFarmakokinetikk | SikkerhetsproblemerStorbritannia
-
Texas A&M UniversityNutraboltFullførtGlucose and Insulin Response
-
Regado Biosciences, Inc.FullførtFrivillig friskForente stater
-
Longeveron Inc.AvsluttetHypoplastisk venstre hjertesyndromForente stater
-
ItalfarmacoFullførtBecker muskeldystrofiNederland, Italia
-
Instituto de Investigación Hospital Universitario...Creaciones Aromáticas Industriales, S.A. (CARINSA)Fullført