GW824575 First Time in Human
A Single-centre, Masked, Placebo-controlled Four Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of the CC-chemokine Receptor 3 (CCR3) Antagonist, GW824575, Coadministered With or Without Food in Healthy Male Subjects
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
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London, Spojené království, NW10 7EW
- GSK Investigational Site
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- For subjects in Parts A or D - Male subjects between 18 and 65 years of age inclusive, at the time of signing the informed consent.
For subjects in Part B - Male subjects greater than or equal to 50 years of age, at the time of signing the informed consent..
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in protocol. This criterion must be followed from the time of the first dose of study medication until 4 months post-last dose.
- Body weight greater than or equal to 55 kg and BMI within the range 18 - 31 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Average QTc < 450 msec.
- Normotensive, after having rested quietly in a supine position for at least 15 minutes, with a systolic blood pressure less than or equal to 120 mmHg and diastolic blood pressure less than or equal to 80mmHg and a heart rate less than or equal to 100 beats per minute. Subjects with "pre-hypertension" (systolic blood pressure 121-140 mmHg and diastolic blood pressure 81 to 99mmHg) must be cleared by the medical monitor.
- Willingness and ability to swallow multiple size 00 capsules as part of study participation.
- For subjects in Part B only - Best-corrected visual acuity better than 20/80 (Snellen equivalent; 54 or more ETDRS letters) in both eyes.
Exclusion Criteria:
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- Significant infection within 4 weeks prior to the first dosing day.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units for males. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months (12 weeks), 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Unable to refrain from prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication and throughout the study, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56-day period.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Any prior intraocular surgery, excluding cataract surgery.
- Any prior eye surgery within three months to first dose of study medication.
- Subjects with glaucoma (controlled or uncontrolled).
- Inability to withhold contact lens wear from the time of the screening ophthalmic assessments until the treatment ophthalmic assessments have been performed (the wearing of glasses is permitted).
- Within 6 months prior to the Screening Visit, use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoxamine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, and ethambutol).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Randomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Trojnásobný
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: GW824575
Investigational treatment - Swedish Orange Coloured, opaque hard gelatin capsule
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Placebo
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Komparátor placeba: GW824575 matched-placebo
Placebo
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Investigational treatment - Swedish Orange Coloured, opaque hard gelatin capsule
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Subject tolerability as measured by the number (and frequency) of subjects who experience adverse events after single ascending doses of GW824575
Časové okno: Parts A and D - Through the expected 48-hour duration of hospital stay.Through the expected 48-hour duration of hospital stay.
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To assess the safety and tolerability of single doses of GW824575 in healthy male subjects.
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Parts A and D - Through the expected 48-hour duration of hospital stay.Through the expected 48-hour duration of hospital stay.
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Subject tolerability as measured by the number (and frequency) of subjects who experience adverse events after repeat doses of GW824575
Časové okno: Part B through the expected 23-day duration of hospital stay.
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To assess the safety and tolerability of repeat doses of GW824575 in healthy male subjects who are greater than or equal to 50 years of age
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Part B through the expected 23-day duration of hospital stay.
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Pharmacokinetic parameters such as Cmax, AUC, half-life, Tmax of GW824575 after single dosing.
Časové okno: Parts A and D - predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours of each hospital stay.
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To characterise the PK profile of single doses of GW824575 in healthy male subjects
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Parts A and D - predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours of each hospital stay.
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Pharmacokinetic parameters such as Cmax, AUC, half-life, Tmax of GW824575 after repeat dosing.
Časové okno: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24, hours on Day 1 of dosing and on Day 21 of dosing in Part B.
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To characterise the PK profile of repeat doses of GW824575 in healthy male subjects who are greater than or equal to 50 years of age
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predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24, hours on Day 1 of dosing and on Day 21 of dosing in Part B.
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Single dose - eosinophil shape change assay
Časové okno: 24 to 27 hours post dose.
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To determine the PD effect of single doses of GW824575 in healthy male subjects.
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24 to 27 hours post dose.
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Repeat dose - eosinophil shape change assay
Časové okno: Part B at 3, 8 and 24 hours post last dose on Day 21.
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To determine the PD effect of repeat doses of GW824575 in healthy male subjects who are greater than 50 years of age
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Part B at 3, 8 and 24 hours post last dose on Day 21.
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Urine, serum and bile sampling for GW824575
Časové okno: Part B (only) at 12-hours after 12 days of repeat dosing.
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To investigate the metabolism of GW824575 following single and repeat doses in healthy male subjects who are greater than or equal to 50 years of age.
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Part B (only) at 12-hours after 12 days of repeat dosing.
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Changes in safety laboratory values after single ascending doses of GW824575
Časové okno: Parts A and D - At the conclusion of the expected 48-hour duration of hospital stay.
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To assess the safety of single dose of GW824575 in healthy male subjects
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Parts A and D - At the conclusion of the expected 48-hour duration of hospital stay.
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Changes in safety laboratory values after repeat dosing with GW824575
Časové okno: Part B through the expected 22-day duration of hospital stay.
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To assess the safety of repeat doses of GW824575 in healthy male subjects who are greater than or equal to 50 years of age
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Part B through the expected 22-day duration of hospital stay.
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 115802
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Studijní data/dokumenty
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Zpráva o klinické studii
Identifikátor informace: 115802Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Plán statistické analýzy
Identifikátor informace: 115802Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Protokol studie
Identifikátor informace: 115802Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Formulář informovaného souhlasu
Identifikátor informace: 115802Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Specifikace datové sady
Identifikátor informace: 115802Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Soubor dat jednotlivých účastníků
Identifikátor informace: 115802Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Formulář komentované zprávy o případu
Identifikátor informace: 115802Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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