- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02259959
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses of BI 1744 CL in Fixed Dose Combination With Tiotropium Bromide in Healthy Male Volunteers
7 oktober 2014 uppdaterad av: Boehringer Ingelheim
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses (2 μg/5 μg, 10 μg/5 μg, and 40 μg/10 μg) of BI 1744 CL in Fixed Dose Combination With Tiotropium Bromide for 14 Days in Healthy Male Volunteers (Double-blind, Randomised, Placebo Controlled [at Each Dose Level] Study)
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL and Tiotropium Bromide when given as fixed dose combination
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
36
Fas
- Fas 1
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år till 45 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion Criteria:
- Healthy male based upon a complete medical history, including physical examination, regarding vital signs (BP, 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 ≤45 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 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 40 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)
The following exclusion criteria are specific for this study due to the known class side effect profile of Tiotropium:
- 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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: Placebo
|
|
Experimentell: BI 1744 CL in combination with Tiotropium
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of subjects with clinically relevant findings in physical examination
Tidsram: Up to day 32
|
Up to day 32
|
|
Number of subjects with clinically relevant findings in vital signs
Tidsram: Up to day 32
|
blood pressure, pulse rate
|
Up to day 32
|
Number of subjects with clinically relevant findings in 12-lead ECG
Tidsram: Up to day 32
|
Up to day 32
|
|
Number of subjects with clinically relevant findings in laboratory tests
Tidsram: Up to day 32
|
Up to day 32
|
|
Number of subjects witch clinically relevant changes in additional safety laboratory test parameters
Tidsram: up to 318 hours after start of treatment
|
Systemic metabolic parameters: cyclic adenosine mono phosphate (cAMP) and potassium
|
up to 318 hours after start of treatment
|
Number of subjects with clinically relevant changes in airway resistance (Raw) measured by body plethysmography
Tidsram: Pre-dose, up to 408 hours after start of treatment
|
Pre-dose, up to 408 hours after start of treatment
|
|
Number of subjects with adverse events
Tidsram: Up to day 32
|
Up to day 32
|
|
Global assessment of tolerability by investigator on a 4-point scale
Tidsram: Up to day 32
|
Up to day 32
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Maximum concentration in plasma (Cmax)
Tidsram: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Time from dosing to maximum concentration in plasma (tmax)
Tidsram: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Area under the concentration-time curve in plasma (AUC)
Tidsram: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Tidsram: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Percentage of AUC 0-∞ that is obtained by extrapolation (%AUCtz-∞)
Tidsram: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Terminal rate constant in plasma (λz)
Tidsram: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Terminal half-life in plasma (t½)
Tidsram: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Mean residence time in the body after inhalation (MRTih)
Tidsram: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Apparent clearance after extravascular administration (CL/F)
Tidsram: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Tidsram: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Amount eliminated in urine from the time point t1 to t2 (Aet1-t2)
Tidsram: up to 336 hours after start of treatment
|
up to 336 hours after start of treatment
|
Fraction excreted in urine from time point t1 to t2 (fet1-t2)
Tidsram: up to 336 hours after start of treatment
|
up to 336 hours after start of treatment
|
Renal clearance from the time point t1 until the time point t2 (CLR,t1-t2)
Tidsram: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Minimum measured concentration in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Tidsram: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Predose concentration of the analytes in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Tidsram: Pre-dose every 24 hours
|
Pre-dose every 24 hours
|
Time of last measurable concentration in plasma (tz)
Tidsram: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Linearity index (LI)
Tidsram: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Accumulation ratio based on Cmax (RA,Cmax)
Tidsram: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Accumulation ratio based on AUCτ (RA,AUC)
Tidsram: up to 504 hours after start of treatment
|
up to 504 hours after start of treatment
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
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Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2007
Primärt slutförande (Faktisk)
1 september 2007
Studieregistreringsdatum
Först inskickad
7 oktober 2014
Först inskickad som uppfyllde QC-kriterierna
7 oktober 2014
Första postat (Uppskatta)
9 oktober 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
9 oktober 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 oktober 2014
Senast verifierad
1 oktober 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Parasympatholytika
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Kolinerga antagonister
- Kolinerga medel
- Bronkdilaterande medel
- Anti-astmatiska medel
- Andningsorgan
- Farmaceutiska lösningar
- Tiotropiumbromid
- Olodaterol
Andra studie-ID-nummer
- 1237.2
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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