- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01215773
Pharmacokinetics, Safety and Tolerability of BI 671800 HEA Given Over 7 Days. A Randomised, Double Blind, Placebo Controlled Within Dose Groups Phase I Study in Healthy Male and Female Volunteers.
31. oktober 2013 oppdatert av: Boehringer Ingelheim
Pharmacokinetics, Safety and Tolerability of BI 671800 HEA Given 200 mg b.i.d. or 400 mg b.i.d. Over 7 Days. A Randomised, Double Blind, Placebo Controlled Within Dose Groups Phase I Study in Healthy Male and Female Volunteers.
The main objectives of the multiple dose study are to investigate the safety, tolerability pharmacokinetics of BI 671800 HEA in healthy male and female volunteers following multiple oral administration of BI 671800
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
24
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Ingelheim, Tyskland
- 1268.59.1 Boehringer Ingelheim Investigational Site
-
-
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 50 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion criteria:
- Healthy males and females according to the following criteria: Based upon a complete medical history, including physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
- Age 21 to 50 years (incl.)
- Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
- 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) deviating from normal and of clinical relevance
- Any 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 or hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half life (>24 h) within one month or less than 10 half-lives of the respective drug prior to first study drug administration
- Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes daily)
- Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in males) or positive alcohol test
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to day 1 of visit 2)
- Any laboratory value outside the reference range that is of clinical relevance, especially repeated Alanine transaminase (ALT), Aspartate transaminase (AST), Gamma-glutamyl-transferase (GGT), Alkaline phosphatase (ALP) or total bilirubin above upper limit of normal (ULN) at screening and not resolved before dosing.
- Inability to comply with dietary regimen of trial site
- Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval within 10 days prior to administration or during the trial, and CYP2C8 substrates such as amiodarone, amodiaquine, paclitaxel, rosiglitazone, pioglitazone and repaglinide or CYP2C9 such as warfarin, tolbutamide, phenytoin, losartan, acenocoumarol within 1 month or six half lives (whichever is greater).
Repeated demonstration of a QTc interval >450 ms, PR interval >230 ms or a QRS interval >120 ms; history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
For female subjects of childbearing potential only:
- Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion
- No adequate contraception during the study including three months before first dosing until 2 month after study completion, e.g. not any of the following: implants, injectables, combined hormonal contraceptives, intrauterine device, or surgical sterilisation (including hysterectomy). In addition to this, also a barrier method (e.g. condom) will be required, if the female is not surgically sterilised.
- Lactation
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: BI 671800 HEA medium dose
Tablet, oral administration with 240 mL of water for each treatment
|
High dose oral administration
Medium dose oral administration
|
Eksperimentell: BI 671800 HEA high dose
2 Tablets, oral administration with 240 mL of water for each treatment
|
High dose oral administration
Medium dose oral administration
|
Placebo komparator: Placebo
Matching to HEA 200 mg tablets, oral administration
|
Matching to HEA 200 mg tablet, oral administration
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Uønskede hendelser
Tidsramme: 12 uker
|
12 uker
|
Vital signs (pulse rate (PR))
Tidsramme: 12 weeks
|
12 weeks
|
Clinical laboratory test (clinical chemistry)
Tidsramme: 12 weeks
|
12 weeks
|
Clinical laboratory test (urinalysis)
Tidsramme: 12 weeks
|
12 weeks
|
Physical examination
Tidsramme: 12 weeks
|
12 weeks
|
Vital signs (blood pressure (BP))
Tidsramme: 12 weeks
|
12 weeks
|
12-lead ECG (electrocardiogram)
Tidsramme: 12 weeks
|
12 weeks
|
Clinical laboratory test (haematology)
Tidsramme: 12 weeks
|
12 weeks
|
Assessment of tolerability by investigator
Tidsramme: 12 weeks
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Cmax (maximum plasma concentration of BI 671800 or BI 600957)
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
tmax (time from dosing until maximum concentration of BI 671800 or BI 600957 is measured)
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
AUC0-infinity (area under the plasma concentration-time curve of BI 671800 or BI 600957 from time of dosing extrapolated to infinity)
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
AUCτ,1 (area under the plasma concentration-time curve of BI 671800 or BI 600957 for the complete dosing interval τ)
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
AUC0-tz (area under the plasma concentration-time curve of BI 671800 or BI 600957 from time of dosing to time tz of last quantifiable concentration)
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
Cmax,ss (maximum plasma concentration of BI 671800 or BI 600957 at steady state)
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
tmax,ss (time from dosing until maximum concentration of BI 671800 or BI 600957 at steady state is measured)
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
Cavg,ss (average measured plasma concentration of BI 671800 or BI 600957 at steady state)
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
AUCτ,ss (area under the plasma concentration-time curve of BI 671800 or BI 600957 at steady state for the complete dosing interval τ)
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
λz,ss (terminal rate constant of BI 671800 or BI 600957 in plasma at steady state)
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
t1/2,ss (terminal half-life of BI 671800 or BI 600957 in plasma at steady state)
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
MRTpo,ss (mean residence time of BI 671800 in the body at steady state after oral administration)
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
CL/F,ss (apparent clearance of BI 671800 at steady state following oral administration)
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
Vz/F,ss (apparent volume of distribution of BI 671800 during the terminal phase at steady state following oral administration)
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
RAUCτ,ss,M/P (ratio of AUCτ,ss of the BI 600957 to AUCτ,ss of BI 671800)
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
RCmax,ss,M/P (ratio of Cmax,ss of the BI 600957 to Cmax,ss of BI 671800)
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
accumulation ratios RA,Cmax
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
accumulation ratios RA,AUC
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
peak-trough fluctuation (PTF) of BI 671800
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
peak-trough fluctuation (PTF) of BI 600957
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
linearity index (LI) of BI 671800 in plasma
Tidsramme: up to day 12 post treatment
|
up to day 12 post treatment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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. oktober 2010
Primær fullføring (Faktiske)
1. desember 2010
Datoer for studieregistrering
Først innsendt
29. september 2010
Først innsendt som oppfylte QC-kriteriene
6. oktober 2010
Først lagt ut (Anslag)
7. oktober 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
1. november 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. oktober 2013
Sist bekreftet
1. oktober 2013
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 1268.59
- 2009-016369-27 (EudraCT-nummer: EudraCT)
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. .
Kliniske studier på Sunn
-
Universidade do PortoFundação para a Ciência e a TecnologiaRekrutteringHealthy People-programmerPortugal
-
VA Office of Research and DevelopmentFullført
-
Universidad Católica del MauleFullført
-
University of MiamiJames and Esther King Biomedical Research ProgramAvsluttetHealthy Lifetime Ikke-røykereForente stater
-
Fundació Institut de Recerca de l'Hospital de la...FullførtHealthy People-programmerSpania
-
University of LeicesterNational Institute for Health Research, United KingdomFullførtPasienter med hjertesvikt og bevart ejeksjonsfraksjon - HFpEF | Pasienter med hjertesvikt med redusert ejeksjonsfraksjon - HFrEF | Healthy Controls Group - alders- og kjønnsmatchet
-
University Hospital, GrenobleUniversity Hospital, Clermont-Ferrand; Grenoble Institut des NeurosciencesAvsluttetParkinsons sykdom | Healthy Controls Group - alders- og kjønnsmatchetFrankrike
Kliniske studier på BI 671800
-
Boehringer IngelheimFullført
-
Boehringer IngelheimFullførtAstma | Rhinitt, Allergisk, FlerårigKorea, Republikken
-
Boehringer IngelheimFullført
-
Boehringer IngelheimFullført
-
Boehringer IngelheimFullførtAstmaForente stater, Australia, Canada, Colombia, Korea, Republikken, Mexico, New Zealand, Peru, Filippinene, Taiwan
-
Boehringer IngelheimFullførtAstma | Rhinitt, Allergisk, SesongbetingetTyskland
-
Boehringer IngelheimFullført
-
Boehringer IngelheimRekrutteringMelanom | Ikke-småcellet lungekreft (NSCLC) | Karsinom, plateepitel i hode og nakke (HNSCC)Nederland