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A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects

21. Oktober 2015 aktualisiert von: Galapagos NV

A Phase I, Open Interaction Study Between Oral Doses of GLPG1837 and Single Doses of Midazolam in Healthy Male Subjects

This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1837 on the single dose pharmacokinetic profile of midazolam administered in fed healthy male subjects. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG1837 and on Day 12 co-administered with GLPG1837, after multiple oral doses of GLPG1837 (daily for 10 days, from Day 2 until Day 11).

Also, the safety and tolerability of multiple oral doses of GLPG1837 co-administered with midazolam in healthy male subjects will be evaluated.

A first dose group of 12 subjects will receive a total daily dose of 500 mg (250 mg b.i.d.) GLPG1837 and a second dose group of 12 subjects will receive a total daily dose of 1000 mg (500 mg b.i.d.) GLPG1837.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

24

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: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Midazolam and 500 mg GLPG1837
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (250 mg b.i.d daily for 10 days) from Days 2 to 11.
Arzneimittel: GLPG1837 500 mg
Each subject will receive multiple oral daily doses of GLPG1837 (250 mg b.i.d. for 11 days) from Days 2 to 12.
Arzneimittel: Midazolam
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).
Experimental: Midazolam and 1000 mg GLPG1837
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (500 mg b.i.d daily for 11 days) from Days 2 to 12.
Arzneimittel: Midazolam
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).
Arzneimittel: GLPG1837 1000 mg
Each subject will receive multiple oral doses of GLPG1837 (500 mg b.i.d. for 11 days) from Days 2 to 12.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
Zeitfenster: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
To characterize the maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma over time before and after multiple doses of GLPG1837 in healthy male subjects
Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
The time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
Zeitfenster: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
To characterize the time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects
Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
The area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple oral doses of GLPG1837
Zeitfenster: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
To characterize the area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple doses of GLPG1837 in healthy male subjects
Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
The apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
Zeitfenster: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
To characterize the apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects
Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Zeitfenster: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
To characterize the maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
Number of adverse events
Zeitfenster: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of the number of adverse events reported
Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
Changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature
Zeitfenster: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature reported
Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
Changes in 12-lead ECG measures
Zeitfenster: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in 12-ECG measures reported
Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
Changes in physical exam measures
Zeitfenster: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in physical examination reported
Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
Changes in blood safety lab parameters
Zeitfenster: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in blood safety lab parameters reported
Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
Changes in urine safety lab parameters
Zeitfenster: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in urine safety lab parameters reported
Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
The time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Zeitfenster: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
To characterize the time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
The area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Zeitfenster: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
To characterize the area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
The apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Zeitfenster: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
To characterize the apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
The metabolite to GLPG1837 ratios in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Zeitfenster: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
To characterize the metabolite to GLPG1837 ratios in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)

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

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • GLPG1837-CL-102
  • 2015-002517-29 (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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