Oral Bioavailability of Solid Formulation of GLPG1837 With and Without Food
keskiviikko 21. lokakuuta 2015 päivittänyt: Galapagos NV
An Open-label Study to Compare the Oral Bioavailability of an Oral Tablet of GLPG1837 Relative to an Oral Suspension After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Oral Tablet
The purpose of the study is to evaluate the amount of GLPG1837 and metabolite present in the blood (relative bioavailability) after a single oral administration of 500 mg GLPG1837 given as an oral suspension under fasted conditions as well as a tablet formulation under fasted and fed conditions, in male healthy subjects.
Also, the safety and tolerability of a single oral dose of 500 mg GLPG1837 given as an oral suspension under fasted conditions as well as a tablet formulation under fasted and fed conditions, will be assessed.
Twelve subjects will receive GLPG1837 on 3 occasions as single dose administrations: as an oral suspension fasted, as an oral tablet, fed and fasted. Treatment administrations will be separated by a wash-out period of at least 6 days.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
12
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Antwerp, Belgia
- SGS LSS Clinical Pharmacology Unit Antwerp
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 50 vuotta (Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Uros
Kuvaus
Inclusion Criteria:
- Healthy male, age 18-50 years
- BMI between 18-30 kg/m2
Exclusion Criteria:
- Any condition that might interfere with the procedures or tests in this study
- Drug or alcohol abuse
- Smoking
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: GLPG1837 as oral suspension fasted
Single dose of 500 mg GLPG1837 as oral suspension after an overnight fast
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A single dose of 500 mg GLPG1837 administered as oral suspension
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Kokeellinen: GLPG1837 as oral tablet fasted
Single dose of 500 mg GLPG1837 as oral tablet after an overnight fast
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A single dose of 500 mg GLPG1837 administered as oral tablet
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Kokeellinen: GLPG1837 as oral tablet fed
Single dose of 500 mg GLPG1837 as oral tablet after a high-fat high-calorie breakfast
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A single dose of 500 mg GLPG1837 administered as oral tablet
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma
Aikaikkuna: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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To characterize and compare the maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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The concentration observed at 24 hours post dose (C24h) of GLPG1837 (metabolite) in plasma
Aikaikkuna: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 2 (24h post dose) in period 3 (last dose of GLPG1837)
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To characterize and compare the concentration observed at 24 hours post dose (C24h) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 2 (24h post dose) in period 3 (last dose of GLPG1837)
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The time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma
Aikaikkuna: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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To characterize and compare the time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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The area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma
Aikaikkuna: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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To characterize and compare the area under the plasma concentration versus time curve of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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The apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma
Aikaikkuna: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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To characterize and compare the apparent terminal half-life of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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The metabolite over GLPG1837 ratios in plasma
Aikaikkuna: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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To characterize and compare the metabolite over GLPG1837 ratios in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Number of adverse events
Aikaikkuna: Between Screening and 7 to 10 days after the last dose of GLPG1837
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To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of number of adverse events (AEs) reported
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Between Screening and 7 to 10 days after the last dose of GLPG1837
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Changes in vital signs as measured by heart rate, blood pressure and oral body temperature
Aikaikkuna: Between Screening and 7 to 10 days after the last dose of GLPG1837
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To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in vital signs as measured by heart rate, blood pressure and oral body temperature reported
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Between Screening and 7 to 10 days after the last dose of GLPG1837
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Changes in 12-lead ECG measures
Aikaikkuna: Between Screening and 7 to 10 days after the last dose of GLPG1837
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To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in 12-ECG measures reported
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Between Screening and 7 to 10 days after the last dose of GLPG1837
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Changes in physical exam measures
Aikaikkuna: Between Screening and 7 to 10 days after the last dose of GLPG1837
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To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in physical examination reported
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Between Screening and 7 to 10 days after the last dose of GLPG1837
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Changes in blood safety lab parameters
Aikaikkuna: Between Screening and 7 to 10 days after the last dose of GLPG1837
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To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in blood safety lab parameters reported
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Between Screening and 7 to 10 days after the last dose of GLPG1837
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Changes in urine safety lab parameters
Aikaikkuna: Between Screening and 7 to 10 days after the last dose of GLPG1837
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To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in urine safety lab parameters reported
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Between Screening and 7 to 10 days after the last dose of GLPG1837
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Tiistai 1. syyskuuta 2015
Ensisijainen valmistuminen (Todellinen)
Torstai 1. lokakuuta 2015
Opintojen valmistuminen (Todellinen)
Torstai 1. lokakuuta 2015
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 23. syyskuuta 2015
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Sunnuntai 27. syyskuuta 2015
Ensimmäinen Lähetetty (Arvio)
Tiistai 29. syyskuuta 2015
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Perjantai 23. lokakuuta 2015
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 21. lokakuuta 2015
Viimeksi vahvistettu
Torstai 1. lokakuuta 2015
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
- GLPG1837-CL-103
- 2015-002518-55 (EudraCT-numero)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .