First-in-Human Single and Multiple Dose of GLPG1205
13. oktober 2013 opdateret af: Galapagos NV
Randomized, Double-blind, Placebo-controlled, Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1205 in Healthy Male Subjects
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated.
Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be characterized compared to placebo.
Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205 will be explored.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Antwerp, Belgien
- SGS LSS Clinical Pharmacology Unit Antwerp
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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
Ingen
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: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: GLPG1205 single dose
Single oral dose of GLPG1205 suspension - ascending doses
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Single dose, oral suspension at 10 mg/mL or 50 mg/mL, starting dose of 10mg escalating up to 800mg
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Placebo komparator: Placebo enkeltdosis
Enkelt oral dosis placebo suspension
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Single dose, oral suspension matching placebo
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Eksperimentel: GLPG1205 multiple doses
Multiple oral doses of GLPG1205 suspension - ascending doses
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Multiple doses, daily for 14 days, oral suspension at 10 mg/mL or 50 mg/mL, anticipated doses: 100mg to 400mg
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Placebo komparator: Placebo flere doser
Flere orale doser placebo suspension
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Flere doser, dagligt i 14 dage, oral suspension matcher placebo
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Safety and tolerability after single dose
Tidsramme: Between screening and 7-10 days after the last dose
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To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
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Between screening and 7-10 days after the last dose
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Safety and tolerability after multiple doses
Tidsramme: Between screening and 7-10 days after the last dose
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To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after multiple oral doses daily for 14 days in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
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Between screening and 7-10 days after the last dose
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The amount of GLPG1205 in plasma and urine over time after a single oral dose
Tidsramme: Between Day 1 predose and 48 hours post dose
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To characterize the amount of GLPG1205 in plasma and urine over time - pharmacokinetics (PK) - after a single oral dose in healthy subjects
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Between Day 1 predose and 48 hours post dose
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The amount of GLPG1205 in plasma and urine over time after multiple oral doses
Tidsramme: Between Day 1 predose and Day 16 (48 hours after the last dose)
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To characterize the amount of GLPG1205 in plasma and urine over time - pharmacokinetics (PK) - after multiple oral doses in healthy subjects
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Between Day 1 predose and Day 16 (48 hours after the last dose)
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Ratio of 6-b-hydroxycortisol/cortisol in urine
Tidsramme: Twelve hours before dosing on Day 1 and Day 14
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To assess the potential of CYP3A4 induction after repeated dosing with GLPG1205 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine
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Twelve hours before dosing on Day 1 and Day 14
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Receptor occupancy by GLPG1205 on blood cells after a single dose
Tidsramme: Day 1 predose up to 24 hours post dose
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To characterize the pharmacodynamics (PD) of GLPG1205 by means of receptor occupancy by GLPG1205 on blood cells after a single oral dose in healthy subjects
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Day 1 predose up to 24 hours post dose
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Receptor occupancy by GLPG1205 on blood cells after multiple doses
Tidsramme: Day 1 and Day 14, predose up to 24 hours post dose
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To characterize the pharmacodynamics (PD) of GLPG1205 by means of receptor occupancy by GLPG1205 on blood cells after multiple oral doses in healthy subjects
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Day 1 and Day 14, predose up to 24 hours post dose
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. juni 2013
Primær færdiggørelse (Faktiske)
1. september 2013
Studieafslutning (Faktiske)
1. oktober 2013
Datoer for studieregistrering
Først indsendt
22. juni 2013
Først indsendt, der opfyldte QC-kriterier
22. juni 2013
Først opslået (Skøn)
26. juni 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. oktober 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. oktober 2013
Sidst verificeret
1. oktober 2013
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- GLPG1205-CL-101
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