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Oral Bioavailability of Solid Formulation of GLPG1837 With and Without Food

21. Oktober 2015 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

12

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Belgien
      • Antwerp, Belgien
        • SGS LSS Clinical Pharmacology Unit Antwerp

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 50 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Männlich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: GLPG1837 as oral suspension fasted
Single dose of 500 mg GLPG1837 as oral suspension after an overnight fast
Arzneimittel: 500 mg GLPG1837 as oral suspension
A single dose of 500 mg GLPG1837 administered as oral suspension
Experimental: GLPG1837 as oral tablet fasted
Single dose of 500 mg GLPG1837 as oral tablet after an overnight fast
Arzneimittel: 500 mg GLPG1837 as oral tablet
A single dose of 500 mg GLPG1837 administered as oral tablet
Experimental: GLPG1837 as oral tablet fed
Single dose of 500 mg GLPG1837 as oral tablet after a high-fat high-calorie breakfast
Arzneimittel: 500 mg GLPG1837 as oral tablet
A single dose of 500 mg GLPG1837 administered as oral tablet

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma
Zeitfenster: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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
Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
The concentration observed at 24 hours post dose (C24h) of GLPG1837 (metabolite) in plasma
Zeitfenster: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 2 (24h post dose) in period 3 (last dose of GLPG1837)
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
Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 2 (24h post dose) in period 3 (last dose of GLPG1837)
The time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma
Zeitfenster: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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
Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
The area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma
Zeitfenster: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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
Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
The apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma
Zeitfenster: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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
Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
The metabolite over GLPG1837 ratios in plasma
Zeitfenster: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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
Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of adverse events
Zeitfenster: Between Screening and 7 to 10 days after the last dose of GLPG1837
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
Between Screening and 7 to 10 days after the last dose of GLPG1837
Changes in vital signs as measured by heart rate, blood pressure and oral body temperature
Zeitfenster: Between Screening and 7 to 10 days after the last dose of GLPG1837
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
Between Screening and 7 to 10 days after the last dose of GLPG1837
Changes in 12-lead ECG measures
Zeitfenster: Between Screening and 7 to 10 days after the last dose of GLPG1837
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
Between Screening and 7 to 10 days after the last dose of GLPG1837
Changes in physical exam measures
Zeitfenster: Between Screening and 7 to 10 days after the last dose of GLPG1837
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
Between Screening and 7 to 10 days after the last dose of GLPG1837
Changes in blood safety lab parameters
Zeitfenster: Between Screening and 7 to 10 days after the last dose of GLPG1837
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
Between Screening and 7 to 10 days after the last dose of GLPG1837
Changes in urine safety lab parameters
Zeitfenster: Between Screening and 7 to 10 days after the last dose of GLPG1837
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
Between Screening and 7 to 10 days after the last dose of GLPG1837

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Galapagos NV

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2015

Primärer Abschluss (Tatsächlich)

1. Oktober 2015

Studienabschluss (Tatsächlich)

1. Oktober 2015

Studienanmeldedaten

Zuerst eingereicht

23. September 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. September 2015

Zuerst gepostet (Schätzen)

29. September 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

23. Oktober 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. Oktober 2015

Zuletzt verifiziert

1. Oktober 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • GLPG1837-CL-103
  • 2015-002518-55 (EudraCT-Nummer)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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