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A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG3067 in Healthy Subjects.

9. April 2018 aktualisiert von: Galapagos NV

Assessment of Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG3067, the Combination of GLPG3067 and GLPG2222, and the Combination of GLPG3067, GLPG2222 and GLPG2737 in Healthy Female Subjects, Including a Relative Bioavailability and Food Effect Part for Single Dose of GLPG3067.

The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled, single center study, evaluating single and multiple ascending oral doses of GLPG3067 and the combination of GLPG3067 and GLPG2222 and the combination of GLPG3067,GLPG2222 and GLPG2737 given for 14 days in healthy women of non-childbearing potential.

The purpose of the study is to evaluate the safety and tolerability of single ascending oral doses and multiple ascending oral doses of GLPG3067 given to healthy women of non-childbearing potential compared to placebo, as well as of multiple oral doses of the combination of GLPG3067/GLPG2222 compared to matching placebo for each compound and multiple oral doses of the combination of GLPG3067/GLPG2222/GLPG2737 compared to matching placebo for each compound.

Studienübersicht

Studientyp

Interventionell

Einschreibung (Tatsächlich)

81

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

      • 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 70 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

Inclusion Criteria:

  • Female subject between 18-70 years of age, inclusive, on the date of signing the informed consent form (ICF).
  • Be of non-childbearing potential defined as surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy), or post-menopausal (at least 12 consecutive months without menstruation, without an alternative medical cause [including hormone replacement therapy]).
  • Have a body mass index between 18-30 kg/m2, inclusive.
  • Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead triplicate electrocardiogram (ECG), and clinical safety laboratory tests prior to the initial study drug administration.
  • Discontinuation of all medications (including over-the-counter and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy for postmenopausal subjects) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) at least 2 weeks prior to the first study drug administration.

Exclusion Criteria:

  • Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
  • Clinically significant symptoms or illness in the 3 months before screening.
  • Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
  • Any laboratory result considered by the investigator as clinically significant prior to study drug administration.
  • Creatinine clearance ≤80 mL/min using the Cockcroft-Gault formula for subjects aged ≤50 years, or creatinine clearance ≤70 mL/min using the Cockcroft-Gault formula for subjects aged >50 years. A 24-hour urine collection to determine the actual value may be performed to confirm creatinine clearance if required.
  • Clinically significant abnormalities of vital signs at screening.
  • Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g. QT interval corrected for heart rate using Fridericia's formula [QTcF] >470 ms) or a known long QT syndrome. A first degree heart block or sinus arrhythmia will not be considered as a significant abnormality.
  • Participation in a drug, drug and device delivery system or combination, or biologic investigational research study within 8 weeks or 5 times the half-life of the investigational drug, if the half-life is known (whichever is longer) prior to initial study drug administration. Subjects who have been dosed previously with GLPG3067 in a clinical trial are allowed to participate Part 4 of this study as long as they completed their last follow-up visit or a washout period of 5 times the half-life of GLPG3067 (whichever is longer) after the last study drug administration is respected.

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: GLPG3067 single dose
Single dose of GLPG3067 oral suspension at up to 6 dose levels in ascending order.
GLPG3067 oral suspension, single ascending doses, daily
Placebo-Komparator: Placebo single dose
Single dose of Placebo oral suspension.
Placebo, oral suspension, daily
Experimental: GLPG3067 oral suspension fed 1
Single dose 1 of GLPG3067 oral suspension after a standardized breakfast.
GLPG3067 oral suspension, single dose, daily
Experimental: GLPG3067 oral tablet fed 1
Single dose 1 of GLPG3067 oral tablet after a standardized breakfast.
GLPG3067 oral tablet, single dose, daily
Experimental: GLPG3067 oral tablet fasted 1
Single dose 1 of GLPG3067 oral tablet after an overnight fast.
GLPG3067 oral tablet, single dose, daily
Experimental: GLPG3067 oral tablet fed 2
Single dose 2 of GLPG3067 oral tablet after a standardized breakfast.
GLPG3067 oral tablet, single dose, daily
Experimental: GLPG3067 oral tablet fed 2 high-fat high-calorie
Single dose 2 of GLPG3067 oral tablet after a high-fat high-calorie breakfast
GLPG3067 oral tablet, single dose, daily
Experimental: GLPG3067 multiple dose
Multiple doses of GLPG3067 oral suspension at up to 5 dose levels in ascending order.
GLPG3067 oral suspension, multiple ascending doses, daily for 14 days
Placebo-Komparator: Placebo multiple dose
Multiple doses of Placebo oral suspension.
Placebo, Suspension zum Einnehmen, täglich für 14 Tage
Experimental: GLPG3067/GLPG2222 multiple dose
Multiple doses of GLPG3067 oral suspension combined with GLPG2222 oral tablet up to 2 dose levels in ascending order.
GLPG3067 oral suspension and GLPG2222 oral tablet, multiple doses, daily for 14 days
Placebo-Komparator: GLPG3067/GLPG2222 Placebo multiple dose
Multiple doses of GLPG3067 matching placebo oral suspension combined with GLPG2222 matching placebo oral tablet.
GLPG3067 matching placebo oral suspension and GLPG2222 matching placebo oral tablet, multiple doses, daily for 14 days
Experimental: GLPG3067/GLPG2222/GLPG2737 multiple dose
Multiple doses of GLPG3067 oral tablet combined with GLPG2222 oral tablet and GLPG2737 oral capsule at up to 2 dose levels in ascending order.
GLPG3067 oral tablet, GLPG2222 oral tablet and GLPG2737 oral capsule, multiple doses, daily for 14 days
Placebo-Komparator: GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose
Multiple doses of GLPG3067 matching placebo oral tablet combined with GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule.
GLPG3067 matching placebo oral tablet, GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule, multiple doses, daily for 14 days

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change versus placebo in the proportion of subjects with adverse events
Zeitfenster: Between screening and 14 days after the last dose
To assess safety and tolerability of single ascending doses, multiple ascending doses of GLPG3067 alone, or in combination with GLPG2222, or in combination with GLPG2222 and GLPG2737 versus placebo in healthy subjects
Between screening and 14 days after the last dose

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Maximum observed plasma concentration of GLPG3067 (Cmax) given alone or in combination with GLPG2222 or in combination with GLPG2222 and GLPG2737
Zeitfenster: Between Day 1 predose and 10 days after the last dose
To characterize pharmacokinetics of GLPG3067 after a single oral dose and of GLPG3067, GLPG2222, and GLPG2737 after multiple oral doses in healthy subjects
Between Day 1 predose and 10 days after the last dose
Area under the plasma concentration-time curve of GLPG3067 (AUC0-t) given alone or in combination with GLPG2222 or in combination with GLPG2222 and GLPG2737
Zeitfenster: Between Day 1 predose and 10 days after the last dose
To characterize pharmacokinetics of GLPG3067 after a single oral dose and of GLPG3067, GLPG2222, and GLPG2737 after multiple oral doses in healthy subjects
Between Day 1 predose and 10 days after the last dose
Ratio of 4-beta-hydroxycholesterol/cholesterol in plasma after multiple oral doses in healthy subjects
Zeitfenster: Day 1 predose and Day 14
To assess the potential for CYP3A4 interaction with GLPG3067, GLPG3067 and GLPG2222, or GLPG3067 and GLPG2222 and GLPG2737
Day 1 predose and Day 14
Maximum observed plasma concentration of GLPG3067 (Cmax) given alone in fed state
Zeitfenster: Between Day 1 predose and 10 days after the last dose
To assess the relative bioavailability of GLPG3067 when given as a single dose of oral suspension or an oral tablet both administered in fed state
Between Day 1 predose and 10 days after the last dose
Concentration in plasma observed at 24 hours post dose (C24h) of GLPG3067 given alone in fed state
Zeitfenster: Between Day 1 predose and 10 days after the last dose
To assess the relative bioavailability of GLPG3067 when given as a single dose of oral suspension or an oral tablet both administered in fed state
Between Day 1 predose and 10 days after the last dose
Area under the plasma concentration-time curve of GLPG3067 (AUC0-t) given alone in fed state
Zeitfenster: Between Day 1 predose and 10 days after the last dose
To assess the relative bioavailability of GLPG3067 when given as a single dose of oral suspension or an oral tablet both administered in fed state
Between Day 1 predose and 10 days after the last dose
Maximum observed plasma concentration of GLPG3067 (Cmax) given alone in fasted state
Zeitfenster: Between Day 1 predose and 10 days after the last dose
To assess the effect of food on the pharmacokinetics of GLPG3067 when given under fasted versus fed conditions
Between Day 1 predose and 10 days after the last dose
Concentration in plasma observed at 24 hours post dose (C24h) of GLPG3067 given alone in fasted state
Zeitfenster: Between Day 1 predose and 10 days after the last dose
To assess the effect of food on the pharmacokinetics of GLPG3067 when given under fasted versus fed conditions
Between Day 1 predose and 10 days after the last dose
Area under the plasma concentration-time curve of GLPG3067 (AUC0-t) given alone in fasted state
Zeitfenster: Between Day 1 predose and 10 days after the last dose
To assess the effect of food on the pharmacokinetics of GLPG3067 when given under fasted versus fed conditions
Between Day 1 predose and 10 days after the last dose

Mitarbeiter und Ermittler

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

Sponsor

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 (Tatsächlich)

28. März 2017

Primärer Abschluss (Tatsächlich)

20. Februar 2018

Studienabschluss (Tatsächlich)

20. Februar 2018

Studienanmeldedaten

Zuerst eingereicht

21. April 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. April 2017

Zuerst gepostet (Tatsächlich)

25. April 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. April 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. April 2018

Zuletzt verifiziert

1. April 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • GLPG3067-CL-101

Plan für individuelle Teilnehmerdaten (IPD)

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Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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