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

9. april 2018 oppdatert av: 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

81

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Antwerp, Belgia
        • SGS LSS Clinical Pharmacology Unit Antwerp

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Eksperimentell: GLPG3067 oral suspension fed 1
Single dose 1 of GLPG3067 oral suspension after a standardized breakfast.
GLPG3067 oral suspension, single dose, daily
Eksperimentell: GLPG3067 oral tablet fed 1
Single dose 1 of GLPG3067 oral tablet after a standardized breakfast.
GLPG3067 oral tablet, single dose, daily
Eksperimentell: GLPG3067 oral tablet fasted 1
Single dose 1 of GLPG3067 oral tablet after an overnight fast.
GLPG3067 oral tablet, single dose, daily
Eksperimentell: GLPG3067 oral tablet fed 2
Single dose 2 of GLPG3067 oral tablet after a standardized breakfast.
GLPG3067 oral tablet, single dose, daily
Eksperimentell: 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
Eksperimentell: 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, oral suspensjon, daglig i 14 dager
Eksperimentell: 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
Eksperimentell: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change versus placebo in the proportion of subjects with adverse events
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximum observed plasma concentration of GLPG3067 (Cmax) given alone or in combination with GLPG2222 or in combination with GLPG2222 and GLPG2737
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. mars 2017

Primær fullføring (Faktiske)

20. februar 2018

Studiet fullført (Faktiske)

20. februar 2018

Datoer for studieregistrering

Først innsendt

21. april 2017

Først innsendt som oppfylte QC-kriteriene

21. april 2017

Først lagt ut (Faktiske)

25. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. april 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. april 2018

Sist bekreftet

1. april 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • GLPG3067-CL-101

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ubestemt

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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