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

21. oktober 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Medicin: Midazolam
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).
Eksperimentel: 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.
Medicin: Midazolam
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Galapagos NV

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2015

Primær færdiggørelse (Faktiske)

1. oktober 2015

Studieafslutning (Faktiske)

1. oktober 2015

Datoer for studieregistrering

Først indsendt

23. september 2015

Først indsendt, der opfyldte QC-kriterier

27. september 2015

Først opslået (Skøn)

29. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GLPG1837-CL-102
  • 2015-002517-29 (EudraCT nummer)

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Placeringer

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