- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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 uppdaterad 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
24
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ingelheim, Tyskland
- 1268.59.1 Boehringer Ingelheim Investigational Site
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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 50 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
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 |
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Experimentell: BI 671800 HEA medium dose
Tablet, oral administration with 240 mL of water for each treatment
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High dose oral administration
Medium dose oral administration
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Experimentell: BI 671800 HEA high dose
2 Tablets, oral administration with 240 mL of water for each treatment
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High dose oral administration
Medium dose oral administration
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Placebo-jämförare: Placebo
Matching to HEA 200 mg tablets, oral administration
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Matching to HEA 200 mg tablet, oral administration
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Biverkningar
Tidsram: 12 veckor
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12 veckor
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Vital signs (pulse rate (PR))
Tidsram: 12 weeks
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12 weeks
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Clinical laboratory test (clinical chemistry)
Tidsram: 12 weeks
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12 weeks
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Clinical laboratory test (urinalysis)
Tidsram: 12 weeks
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12 weeks
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Physical examination
Tidsram: 12 weeks
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12 weeks
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Vital signs (blood pressure (BP))
Tidsram: 12 weeks
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12 weeks
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12-lead ECG (electrocardiogram)
Tidsram: 12 weeks
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12 weeks
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Clinical laboratory test (haematology)
Tidsram: 12 weeks
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12 weeks
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Assessment of tolerability by investigator
Tidsram: 12 weeks
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12 weeks
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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Cmax (maximum plasma concentration of BI 671800 or BI 600957)
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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tmax (time from dosing until maximum concentration of BI 671800 or BI 600957 is measured)
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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AUC0-infinity (area under the plasma concentration-time curve of BI 671800 or BI 600957 from time of dosing extrapolated to infinity)
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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AUCτ,1 (area under the plasma concentration-time curve of BI 671800 or BI 600957 for the complete dosing interval τ)
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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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)
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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Cmax,ss (maximum plasma concentration of BI 671800 or BI 600957 at steady state)
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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tmax,ss (time from dosing until maximum concentration of BI 671800 or BI 600957 at steady state is measured)
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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Cavg,ss (average measured plasma concentration of BI 671800 or BI 600957 at steady state)
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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AUCτ,ss (area under the plasma concentration-time curve of BI 671800 or BI 600957 at steady state for the complete dosing interval τ)
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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λz,ss (terminal rate constant of BI 671800 or BI 600957 in plasma at steady state)
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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t1/2,ss (terminal half-life of BI 671800 or BI 600957 in plasma at steady state)
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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MRTpo,ss (mean residence time of BI 671800 in the body at steady state after oral administration)
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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CL/F,ss (apparent clearance of BI 671800 at steady state following oral administration)
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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Vz/F,ss (apparent volume of distribution of BI 671800 during the terminal phase at steady state following oral administration)
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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RAUCτ,ss,M/P (ratio of AUCτ,ss of the BI 600957 to AUCτ,ss of BI 671800)
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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RCmax,ss,M/P (ratio of Cmax,ss of the BI 600957 to Cmax,ss of BI 671800)
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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accumulation ratios RA,Cmax
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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accumulation ratios RA,AUC
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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peak-trough fluctuation (PTF) of BI 671800
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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peak-trough fluctuation (PTF) of BI 600957
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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linearity index (LI) of BI 671800 in plasma
Tidsram: up to day 12 post treatment
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up to day 12 post treatment
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
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 oktober 2010
Primärt slutförande (Faktisk)
1 december 2010
Studieregistreringsdatum
Först inskickad
29 september 2010
Först inskickad som uppfyllde QC-kriterierna
6 oktober 2010
Första postat (Uppskatta)
7 oktober 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
1 november 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 oktober 2013
Senast verifierad
1 oktober 2013
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 1268.59
- 2009-016369-27 (EudraCT-nummer: EudraCT)
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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