- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03143725
Study to Compare Bioavailability of GLPG1972 Given as 2 Different Tablet Formulations Versus an Oral Solution
19 juni 2017 uppdaterad av: Galapagos NV
Open-label Study to Compare the Bioavailability of an Oral Wet Granulation Tablet of GLPG1972 Relative to an Oral Solution and to an Oral Direct Compression Tablet After Single-dose Intake in Healthy Subjects, and to Evaluate the Effect of Food on the Bioavailability of an Oral Wet Granulation Tablet.
This study is a Phase I, randomized, open-label, cross-over study with 4 single-dose treatments of GLPG1972 to compare the bioavailability of the oral wet granulation (WG) tablet relative to an oral solution and to the oral direct compression (DC) tablet after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the WG oral tablet.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
12
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Antwerp, Belgien
- SGS Belgium Life Sciences
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 50 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion Criteria:
- Male between 18 and 50 years of age, inclusive,
- A body mass index (BMI) between 18-30 kg/m², inclusive, weight of at least 50 kg.
- Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory findings.
- Discontinuation of all medications except occasional paracetamol at least 2 weeks or 5 half-lives prior to the first study drug administration.
- Non-smokers and not using any nicotine-containing products.
- Negative urine drug screen and alcohol breath test.
- Current sexually active male agrees to use adequate contraception
- Willing to consume a non-vegetarian high-fat and high-calorie breakfast
- Able and willing to sign the ICF
Exclusion Criteria:
- Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
- Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or any history of hepatitis from any cause with the exception of hepatitis A.
- History of or a current immunosuppressive condition
- Symptoms of clinically significant illness in the 3 months before the initial study drug administration.
- History of malignancy within the past 5 years
- Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g. QTcF >450 msec, or a known long QT syndrome).
- Presence of abnormal liver function
- Renal function with an estimated creatinine clearance <80 ml/min based on the Cockcroft-Gault formula.
- Presence of any condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Clinically relevant abnormalities detected on "vital signs"
- Dietary requirements precluding participation.
- Significant blood loss including blood donation or had a transfusion of any blood product within 12 weeks
- Hemoglobin level <7.5 mmol/L (12 g/dL).
- Active drug or alcohol abuse within 2 years prior to the initial study drug administration.
- Current (2 weeks before screening) and planned uninterrupted consumption of large quantities (> 6 cups) of coffee
- Administration of an injectable drug within 30 days prior to the initial study drug administration.
- Concurrent participation, or participation in a drug/device study within 8 weeks or 5 half-lives of the drug or within 6 months for biologicals
- Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Treatment A
GLPG1972 oral solution after overnight fast
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Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)
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Experimentell: Treatment B
GLPG1972 oral DC tablet after breakfast
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Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)
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Experimentell: Treatment C
GLPG1972 oral WG tablet after overnight fast
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Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)
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Experimentell: Treatment D
GLPG1972 oral WG tablet after breakfast
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Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Assessment of the maximum observed plasma concentration of GLPG1972 after single oral doses
Tidsram: on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
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Determine bioavailability of GLPG1972 by assessing PK parameters
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on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
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Assessment of plasma concentration of GLPG1972 24hrs post-dose after single oral doses
Tidsram: At 24 hours post dose
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Determine bioavailability of GLPG1972 by assessing PK parameters
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At 24 hours post dose
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Assessment of time to achieve the maximal plasma concentration of GLPG1972 after single oral doses
Tidsram: on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
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Determine bioavailability of GLPG1972 by assessing PK parameters
|
on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
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Assessment of the last quantifiable plasma concentration of GLPG1972 after single oral doses
Tidsram: on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
|
Determine bioavailability of GLPG1972 by assessing PK parameters
|
on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
the number of subjects with adverse events
Tidsram: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
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To assess safety and tolerability of GLPG1972 given orally
|
at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
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the number of subjects with abnormal vital signs
Tidsram: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
|
To assess safety and tolerability of GLPG1972 given orally
|
at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
|
the number of subjects with abnormal ECG
Tidsram: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
|
To assess safety and tolerability of GLPG1972 given orally
|
at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
|
the number of subjects with abnormal laboratory assessments
Tidsram: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
|
To assess safety and tolerability of GLPG1972 given orally
|
at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Ann Fieuw, MD MSc, Galapagos NV
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
14 april 2017
Primärt slutförande (Faktisk)
6 juni 2017
Avslutad studie (Faktisk)
6 juni 2017
Studieregistreringsdatum
Först inskickad
4 maj 2017
Först inskickad som uppfyllde QC-kriterierna
4 maj 2017
Första postat (Faktisk)
8 maj 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 juni 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 juni 2017
Senast verifierad
1 juni 2017
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- GLPG1972-CL-105
Plan för individuella deltagardata (IPD)
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