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- Sperimentazione clinica NCT02171806
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BI 1744 CL in Healthy Male and Female Volunteers
20 giugno 2014 aggiornato da: Boehringer Ingelheim
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses (2.5 μg, 10 μg, and 30 μg) of BI 1744 CL for 14 Days in Healthy Male and Female Volunteers (Doubleblind, Randomised, Placebo Controlled [at Each Dose Level] Study)
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
47
Fase
- Fase 1
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 21 anni a 50 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Healthy male or female 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. There is no finding deviating from normal and of clinical relevance. There is no evidence of a 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 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 randomisation
- 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 randomisation
- Participation in another trial with an investigational drug within 2 months prior to randomisation
- 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 (more than 60 g alcohol a day)
- 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 randomisation 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
The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:
- Asthma or history of pulmonary hyperreactivity
- Hyperthyrosis
- Allergic rhinitis in need of treatment
- Clinically relevant cardiac arrhythmia
- Paroxysmal tachycardia (>100 beats per minute).
For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraception, sterilisation, IUD (intrauterine device). Females who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condoms) prior to administration of study medication, during the study and at least 2 months after release from the study.
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore placebo: Placebo
|
|
Sperimentale: BI 1744 CL multiple rising doses
|
|
Sperimentale: BI 1744 CL medium dose, females
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Number of patients with clinically significant changes in physical examination
Lasso di tempo: Baseline, day 32 (end-of-study examination)
|
Baseline, day 32 (end-of-study examination)
|
Number of patients with clinically significant changes in vital signs
Lasso di tempo: Baseline, up to day 32
|
Baseline, up to day 32
|
Number of patients with clinically significant changes in 12-lead ECG (Electrocardiogram)
Lasso di tempo: Baseline, up to day 32
|
Baseline, up to day 32
|
Number of patients with abnormal changes in laboratory tests
Lasso di tempo: Baseline, up to day 32
|
Baseline, up to day 32
|
Changes in airway resistance (Raw) measured by body plethysmography
Lasso di tempo: Baseline, up to day 32
|
Baseline, up to day 32
|
Changes in tremormetry parameters
Lasso di tempo: Baseline, up to day 32
|
Baseline, up to day 32
|
Number of patients with adverse events
Lasso di tempo: Up to day 32
|
Up to day 32
|
Assessment of tolerability by the investigator on a 4-point scale
Lasso di tempo: Day 32 (end-of-study examination)
|
Day 32 (end-of-study examination)
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Cmax (maximum concentration of the analyte in plasma)
Lasso di tempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
tmax (time from dosing to maximum concentration)
Lasso di tempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
AUC (area under the concentration-time curve of the analyte in plasma at different time points)
Lasso di tempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
Aet1-t2(amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Lasso di tempo: Up to 384 hours after drug administration
|
Up to 384 hours after drug administration
|
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Lasso di tempo: Up to 384 hours after drug administration
|
Up to 384 hours after drug administration
|
%AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation)
Lasso di tempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
λz (terminal rate constant of the analyte in plasma)
Lasso di tempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
t½ (terminal half-life of the analyte in plasma)
Lasso di tempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
MRTih (mean residence time of the analyte in the body after inhalation)
Lasso di tempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Lasso di tempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
Vz/F (apparent volume of distribution of the analyte during the terminal phase λz following an extravascular dose)
Lasso di tempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 until the time point t2)
Lasso di tempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
RA,Cmax,14 based on Cmax (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ)
Lasso di tempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
RA,AUC,14 based on AUC0-τ
Lasso di tempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Lasso di tempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Lasso di tempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
Linearity Index (LI)
Lasso di tempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
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Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2006
Completamento primario (Effettivo)
1 settembre 2006
Date di iscrizione allo studio
Primo inviato
20 giugno 2014
Primo inviato che soddisfa i criteri di controllo qualità
20 giugno 2014
Primo Inserito (Stima)
24 giugno 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
24 giugno 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 giugno 2014
Ultimo verificato
1 giugno 2014
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1222.2
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .