Een onderzoek bij gezonde mannen om te testen hoe goed verschillende doses BI 1569912 worden verdragen en hoe voedsel de hoeveelheid BI 1569912 in het bloed beïnvloedt
Veiligheid, verdraagbaarheid, farmacokinetiek en farmacodynamiek van enkelvoudig stijgende orale doses van BI 1569912 bij gezonde mannelijke proefpersonen (enkelblind, gedeeltelijk gerandomiseerd binnen dosisgroepen, placebogecontroleerd, parallelgroepontwerp) met een aanvullend deel over relatieve biologische beschikbaarheid/voedseleffect (open -label, gerandomiseerd, drievoudig crossover-ontwerp)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Berlin, Duitsland, 10117
- Charité - Universitätsmedizin Berlin
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Beschrijving
Inclusiecriteria:
- Gezonde mannelijke proefpersonen volgens de beoordeling van de onderzoeker, gebaseerd op een volledige medische geschiedenis inclusief een lichamelijk onderzoek, vitale functies (bloeddruk (BP), hartslag (PR), ademhalingsfrequentie (RR), temperatuur (T)), 12-afleidingen ECG en klinische laboratoriumtests
- Leeftijd van 18 tot 45 jaar (inclusief)
- BMI van 18,5 tot 29,9 kg/m2 (inclusief)
- Ondertekende en gedateerde schriftelijke geïnformeerde toestemming voorafgaand aan toelating tot het onderzoek, in overeenstemming met GCP en lokale wetgeving
Mannelijke proefpersonen die voldoen aan een van de volgende criteria vanaf ten minste 30 dagen vóór de eerste toediening van proefmedicatie tot 30 dagen na voltooiing van de proef:
- Gebruik van adequate anticonceptie, b.v. een van de volgende methoden (van vrouwelijke partners) plus condoom: implantaten, injecties, gecombineerde orale of vaginale anticonceptiva, spiraaltje
- Seksueel onthouding
- Chirurgisch gesteriliseerd (inclusief hysterectomie van vrouwelijke partner)
- Postmenopauzale vrouwelijke partner, gedefinieerd als ten minste 1 jaar spontane amenorroe (in twijfelachtige gevallen is een bloedmonster met follikelstimulerend hormoon (FSH) boven 40 U/L en oestradiol onder 30 ng/L bevestigend)
Uitsluitingscriteria:
- Elke bevinding in het medisch onderzoek (inclusief BP, PR of ECG) die afwijkt van normaal en door de onderzoeker als klinisch relevant wordt beoordeeld
- Herhaalde meting van systolische bloeddruk buiten het bereik van 90 tot 140 mmHg, diastolische bloeddruk buiten het bereik van 50 tot 90 mmHg, of hartslag buiten het bereik van 50 tot 90 spm
- Elke laboratoriumwaarde buiten het referentiebereik die de onderzoeker als klinisch relevant beschouwt, in het bijzonder leverparameters (alanineaminotransferase (ALT), aspartaataminotransferase (AST), totaal bilirubine) of nierparameters (creatinine) die de bovengrens van normaal overschrijden (ULN) na herhaalde metingen
- Elk bewijs van een bijkomende ziekte die door de onderzoeker als klinisch relevant is beoordeeld
- Gastro-intestinale, lever-, nier-, ademhalings-, cardiovasculaire, metabolische, immunologische of hormonale stoornissen
- Cholecystectomie of andere operatie van het maagdarmkanaal die de farmacokinetiek van de proefmedicatie zou kunnen verstoren (behalve appendectomie of eenvoudig herstel van een hernia)
- Geschiedenis van relevante orthostatische hypotensie, flauwvallen of onverklaarbare black-outs
- Chronische of relevante acute infecties
- Een positieve polymerasekettingreactie (PCR)-test voor SARS-CoV-2/COVID-19 en/of enig klinisch symptoom dat wijst op deze ziekte bij de screening en op Dag -3.
Verdere uitsluitingscriteria zijn van toepassing.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: SRD part: Placebo
This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered on Day 1 a single oral dose of matching placebo (the matching placebo is only the solvent for oral solution (Tartaric acid 5 mg/mL) on a volume identical to dose group (DG) of active treatment ) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. |
Placebo
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Experimenteel: SRD part: 0.25mg BI 1569912
Participants were administered on Day 1 a single oral dose of 0.25 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 0.4 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
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BI 1569912
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Experimenteel: SRD part: 0.75mg BI 1569912
Participants were administered on Day 1 a single oral dose of 0.75 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 1.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
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BI 1569912
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Experimenteel: SRD part: 2.0 mg BI 1569912
Participants were administered on Day 1 a single oral dose of 2.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 3.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
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BI 1569912
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Experimenteel: SRD part: 5.0 mg BI 1569912
Participants were administered on Day 1 a single oral dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
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BI 1569912
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Experimenteel: SRD part: 10.0 mg BI 1569912
Participants were administered on Day 1 a single oral dose of 10.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 16 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
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BI 1569912
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Experimenteel: SRD part: 20.0 mg BI 1569912
Participants were administered on Day 1 a single oral dose of 20.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 32 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
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BI 1569912
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Experimenteel: SRD part: 30.0 mg BI 1569912
Participants were administered on Day 1 a single oral dose of 30.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 48 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
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BI 1569912
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Experimenteel: BA/FE Part: BI 1569912 5.0 mg oral solution fasted/5.0 mg tablet fasted/5.0 mg tablet fed
Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. One authorized employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. |
BI 1569912
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Experimenteel: BA/FE Part: BI 1569912 5.0 mg oral solution fasted/5.0 mg tablet fed/5.0 mg tablet fasted
Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. |
BI 1569912
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Experimenteel: BA/FE Part: BI 1569912 5.0 mg tablet fasted/5.0 mg oral solution fasted/5.0 mg tablet fed
Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. |
BI 1569912
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Experimenteel: BA/FE Part: BI 1569912 5.0 mg tablet fasted/5.0 mg tablet fed/5.0 mg oral solution fasted
Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. |
BI 1569912
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Experimenteel: BA/FE Part: BI 1569912 5.0 mg tablet fed/5.0 mg oral solution fasted/5.0 mg tablet fasted
Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. |
BI 1569912
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Experimenteel: BA/FE Part: BI 1569912 5.0 mg tablet fed/5.0 mg tablet fasted/5.0 mg oral solution fasted
Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. |
BI 1569912
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Part SRD: Number of Subjects With Drug-related Adverse Events (AEs)
Tijdsspanne: From drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. Up to 14.5 days.
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Number of participants with drug-related adverse events (AEs) is presented for SRD part. Percentage of participants with treatment-emergent drug-related Adverse Events (AEs) is reported. Percentages are calculated using total number of subjects per treatment as the denominator. |
From drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. Up to 14.5 days.
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BA/FE-Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Tijdsspanne: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.
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Area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
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Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.
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BA/FE-Part: Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
Tijdsspanne: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.
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Maximum measured concentration of BI 1569912 in plasma (Cmax) is presented.
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Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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SRD Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to Infinity (AUC0-∞)
Tijdsspanne: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h30min, 2h30min, 3h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, after BI 1569912 administration.
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Area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to infinity (AUC0-∞) is presented.
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Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h30min, 2h30min, 3h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, after BI 1569912 administration.
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SRD-Part: Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
Tijdsspanne: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h30min, 2h30min, 3h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, after BI 1569912 administration.
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Maximum measured concentration of BI 1569912 in plasma (Cmax) is presented.
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Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h30min, 2h30min, 3h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, after BI 1569912 administration.
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BA/FE-Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to Infinity (AUC0-∞)
Tijdsspanne: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.
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Area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to infinity (AUC0-∞) is presented.
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Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.
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Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 1447-0001
- 2019-004836-51 (EudraCT-nummer)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Klinische studies gesponsord door Boehringer Ingelheim, fasen I tot IV, interventioneel en niet-interventioneel, komen in aanmerking voor het delen van de ruwe klinische onderzoeksgegevens en klinische onderzoeksdocumenten, met uitzondering van de volgende uitsluitingen:
1. studies in producten waarvan Boehringer Ingelheim niet de licentiehouder is; 2. studies met betrekking tot farmaceutische formuleringen en bijbehorende analytische methoden, en studies met betrekking tot farmacokinetiek met behulp van menselijke biomaterialen; 3. studies uitgevoerd in één enkel centrum of gericht op zeldzame ziekten (vanwege beperkingen met anonimisering).
Zie voor meer details: https://www.mystudywindow.com/msw/datasharing
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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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