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- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Placebo
|
|
Expérimental: BI 1744 CL - single rising dose + Tiotropium
Single rising dose of BI 1744 CL (conjointly with Tiotropium bromide)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Évaluation de la tolérance par l'investigateur sur une échelle de 4 points
Délai: 12 jours après l'administration du médicament
|
12 jours après l'administration du médicament
|
|
Number of participants with abnormal findings in physical examination
Délai: up to 12 days after drug administration
|
up to 12 days after drug administration
|
|
Number of participants with abnormal changes in laboratory parameters
Délai: up to 12 days after drug administration
|
up to 12 days after drug administration
|
|
Number of participants with clinically significant changes in vital signs
Délai: 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
Délai: 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
Délai: 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
Délai: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
|
Number of abnormal findings on pulmonary auscultation
Délai: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
|
Change in Airway resistance (Raw)
Délai: up to 24 hours after drug administration
|
measured by whole-body plethysmography
|
up to 24 hours after drug administration
|
Change in specific conductance (sGaw)
Délai: up to 24 hours after drug administration
|
measured by whole-body plethysmography
|
up to 24 hours after drug administration
|
Change in Cyclic aminomonophosphate (cAMP)
Délai: up to 6 hours after drug administration
|
up to 6 hours after drug administration
|
|
Change in potassium
Délai: up to 6 hours after drug administration
|
up to 6 hours after drug administration
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
λz (constante de vitesse terminale dans le plasma)
Délai: jusqu'à 96 heures après l'administration du médicament
|
jusqu'à 96 heures après l'administration du médicament
|
Vz/F (volume de distribution apparent pendant la phase terminale λz suite à une dose extravasculaire)
Délai: jusqu'à 96 heures après l'administration du médicament
|
jusqu'à 96 heures après l'administration du médicament
|
Cmax (maximum measured concentration of BI 1744 BS and tiotropium in plasma)
Délai: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
tmax (time from dosing to maximum measured concentration)
Délai: 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)
Délai: 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)
Délai: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
%AUCtz-∞ (percentage of the extrapolated part of the total AUC0-∞)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: up to 96 hours after drug administration
|
up to 96 hours after drug administration
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Parasympatholytiques
- Agents autonomes
- Agents du système nerveux périphérique
- Antagonistes cholinergiques
- Agents cholinergiques
- Anticonvulsivants
- Agents bronchodilatateurs
- Agents anti-asthmatiques
- Agents du système respiratoire
- Bromure de tiotropium
- Bromures
- Olodatérol
Autres numéros d'identification d'étude
- 1237.1
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