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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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Placebo-vergelijker: Placebo
|
|
Experimenteel: BI 1744 CL - single rising dose + Tiotropium
Single rising dose of BI 1744 CL (conjointly with Tiotropium bromide)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Beoordeling van de verdraagbaarheid door de onderzoeker op een 4-puntsschaal
Tijdsspanne: 12 dagen na toediening van het geneesmiddel
|
12 dagen na toediening van het geneesmiddel
|
|
Number of participants with abnormal findings in physical examination
Tijdsspanne: up to 12 days after drug administration
|
up to 12 days after drug administration
|
|
Number of participants with abnormal changes in laboratory parameters
Tijdsspanne: up to 12 days after drug administration
|
up to 12 days after drug administration
|
|
Number of participants with clinically significant changes in vital signs
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
|
Number of abnormal findings on pulmonary auscultation
Tijdsspanne: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
|
Change in Airway resistance (Raw)
Tijdsspanne: up to 24 hours after drug administration
|
measured by whole-body plethysmography
|
up to 24 hours after drug administration
|
Change in specific conductance (sGaw)
Tijdsspanne: up to 24 hours after drug administration
|
measured by whole-body plethysmography
|
up to 24 hours after drug administration
|
Change in Cyclic aminomonophosphate (cAMP)
Tijdsspanne: up to 6 hours after drug administration
|
up to 6 hours after drug administration
|
|
Change in potassium
Tijdsspanne: up to 6 hours after drug administration
|
up to 6 hours after drug administration
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
λz (eindsnelheidsconstante in plasma)
Tijdsspanne: tot 96 uur na toediening van het geneesmiddel
|
tot 96 uur na toediening van het geneesmiddel
|
Vz/F (schijnbaar distributievolume tijdens de terminale fase λz na een extravasculaire dosis)
Tijdsspanne: tot 96 uur na toediening van het geneesmiddel
|
tot 96 uur na toediening van het geneesmiddel
|
Cmax (maximum measured concentration of BI 1744 BS and tiotropium in plasma)
Tijdsspanne: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
tmax (time from dosing to maximum measured concentration)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
%AUCtz-∞ (percentage of the extrapolated part of the total AUC0-∞)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Fysiologische effecten van medicijnen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Parasympathicolytica
- Autonome agenten
- Agenten van het perifere zenuwstelsel
- Cholinerge antagonisten
- Cholinerge middelen
- Anticonvulsiva
- Bronchusverwijdende middelen
- Anti-astmatische middelen
- Agenten van het ademhalingssysteem
- Tiotropiumbromide
- Bromiden
- Olodaterol
Andere studie-ID-nummers
- 1237.1
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