- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02171793
Single Rising Peroral Doses of BI 1744 CL in Healthy Volunteers
20. juni 2014 oppdatert av: Boehringer Ingelheim
A Randomised, Single-blind, Placebo-controlled (Within Dose Groups) Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Peroral Doses (15, 30, 40 μg Free Cation) BI 1744 CL in Healthy Male Volunteers
Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral doses of BI 1744 CL.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
24
Fase
- Fase 1
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år til 45 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- 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 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 enrolment in the study or during the study
- Participation in another trial with an investigational drug within 30 days 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 (regularly more than 40 g alcohol per 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 β2 mimetic drugs:
- Asthma or history of pulmonary hyperreactivity
- Hyperthyrosis
- Allergic rhinitis in need of treatment
- Clinically relevant cardiac arrhythmia
- Paroxysmal tachycardia (>100 beats per minute)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Placebo
|
|
Eksperimentell: BI 1744 CL
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of patients with abnormal findings in physical examination
Tidsramme: Baseline, day 17
|
Baseline, day 17
|
Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR), respiration rate (RR), oral body temperature)
Tidsramme: Baseline, up to day 17
|
Baseline, up to day 17
|
Number of patients with clinically relevant abnormal findings in 12-lead electrocardiogram (ECG)
Tidsramme: Baseline, up to day 17
|
Baseline, up to day 17
|
Number of patients with clinically significant changes in clinical laboratory tests
Tidsramme: Baseline, up to day 17
|
Baseline, up to day 17
|
Number of patients with Adverse events (AEs)
Tidsramme: 5 weeks
|
5 weeks
|
Assessment of tolerability by investigator on a 4-point scale
Tidsramme: Day 17
|
Day 17
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Cmax (maximum measured concentration of the analyte in plasma)
Tidsramme: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Tidsramme: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Tidsramme: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Tidsramme: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Tidsramme: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
λz (terminal rate constant in plasma)
Tidsramme: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
t1/2 (terminal half-life of the analyte in plasma)
Tidsramme: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
MRTpo (mean residence time of the analyte in the body after peroral administration)
Tidsramme: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
CL/F (apparent clearance of the analyte in plasma after peroral administration, will not be calculated for metabolites)
Tidsramme: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
Vz/F (apparent volume of distribution during the terminal phase λz following a peroral dose, will not be calculated for metabolites)
Tidsramme: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
|
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Tidsramme: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h after drug administration
|
pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h after drug administration
|
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Tidsramme: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h after drug administration
|
pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h after drug administration
|
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Tidsramme: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h after drug administration
|
pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h after drug administration
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
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Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2007
Primær fullføring (Faktiske)
1. juli 2007
Datoer for studieregistrering
Først innsendt
20. juni 2014
Først innsendt som oppfylte QC-kriteriene
20. juni 2014
Først lagt ut (Anslag)
24. juni 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
24. juni 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. juni 2014
Sist bekreftet
1. juni 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1222.19
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. .
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