- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02256787
Safety, Tolerance, and Pharmacokinetics of Single Rising Oral Doses of BILB 1941 ZW Solution in Healthy Male Subjects, Followed With Bioavailability Comparison of BILB 1941 ZW Tablet and Solution Formulation Administered With or Without Food
2. oktober 2014 oppdatert av: Boehringer Ingelheim
Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of 5 mg, 20 mg, 60 mg, 120 mg, 200 mg, 300 mg, 600 mg, 1000 mg, 1500 mg, 2000 mg, 2400 mg, and 3000 mg BILB 1941 ZW (PEG 400/TRIS Solution) in Healthy Male Subjects, in a Randomised Double Blind, Placebo Controlled Rising Dose Study, Followed With an Open-label Intra-subject Three-Way Crossover Bioavailability Comparison of 600 mg BILB 1941 ZW in a PEG 400/TRIS Solution and 600 mg BILB 1941 ZW Tablet and 600 mg BILB 1941 ZW Tablet Administered With Food
The objective of the current study was to investigate the safety, tolerability, and pharmacokinetics of BILB 1941 ZW following the administration of single rising doses from 5 mg to 300 mg.
In addition the bioavailability of the 60 mg dose given fasted and after a high-fat breakfast was to be be investigated
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
56
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
18 år til 50 år (Voksen)
Tar imot friske frivillige
Ja
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:
1.1 No finding deviating from normal and of clinical relevance
1.2 No evidence of a clinically relevant concomitant disease
- Age ≥18 and Age ≤50 years, BMI ≥18.5 and BMI ≤29.9 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 blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection
- History of orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
- Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within 1 month prior to administration or during the trial
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation of more than 100 mL within 1 month prior to administration or during the trial
- Excessive physical activities within 5 days prior to administration or during the trial
- Any laboratory value outside the clinically accepted reference range and of clinical relevance
- History of any familial bleeding disorder
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: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: BILB 1941 ZW - single rising dose
Single rising dose part
|
|
Placebo komparator: Placebo
Single rising dose part
|
|
Eksperimentell: BILB 1941 ZW - tablet - fasted
Relative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast
|
|
Eksperimentell: BILB 1941 ZW - solution
Relative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast
|
|
Eksperimentell: BILB 1941 ZW - tablet - fed
Relative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of subjects with abnormal findings in physical examination
Tidsramme: up to 48 hours following drug administration
|
up to 48 hours following drug administration
|
|
Number of subjects with abnormal changes in laboratory parameters
Tidsramme: up to 48 hours following drug administration
|
up to 48 hours following drug administration
|
|
Number of subjects with clinically significant changes in vital signs
Tidsramme: up to 48 hours following drug administration
|
Blood pressure, Pulse Rate
|
up to 48 hours following drug administration
|
Number of subjects with adverse events
Tidsramme: up to 48 hours following drug administration
|
up to 48 hours following drug administration
|
|
Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram)
Tidsramme: up to 48 hours following drug administration
|
up to 48 hours following drug administration
|
|
Assessment of tolerability by investigator on a 4-point scale
Tidsramme: after 48 hours following drug administration
|
after 48 hours following drug administration
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Cmax (maximum concentration of the analyte in plasma)
Tidsramme: up to 48 hours following drug administration
|
up to 48 hours following drug administration
|
tmax (time from dosing to maximum concentration)
Tidsramme: up to 48 hours following drug administration
|
up to 48 hours following drug administration
|
AUC0-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Tidsramme: up to 48 hours following drug administration
|
up to 48 hours following drug administration
|
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Tidsramme: up to 48 hours following drug administration
|
up to 48 hours following drug administration
|
λz (terminal rate constant in plasma)
Tidsramme: up to 48 hours following drug administration
|
up to 48 hours following drug administration
|
t1/2 (terminal half-life of the analyte in plasma)
Tidsramme: up to 48 hours following drug administration
|
up to 48 hours following drug administration
|
MRT (Mean time of residence of drug molecules in the body after intravascular administration)
Tidsramme: up to 48 hours following drug administration
|
up to 48 hours following drug administration
|
Vz/F (Apparent volume of distribution during the terminal phase after extravascular administration)
Tidsramme: up to 48 hours following drug administration
|
up to 48 hours following 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
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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. januar 2004
Primær fullføring (Faktiske)
1. september 2004
Datoer for studieregistrering
Først innsendt
2. oktober 2014
Først innsendt som oppfylte QC-kriteriene
2. oktober 2014
Først lagt ut (Anslag)
6. oktober 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. oktober 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. oktober 2014
Sist bekreftet
1. oktober 2014
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 1201.1
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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