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- Klinische proef NCT00605852
Investigation Of a New Oral Anti-Histamine in Healthy Male Subjects
16 augustus 2017 bijgewerkt door: GlaxoSmithKline
A Double-blind, Placebo-controlled, Randomized Cross-over Single Dose Escalation Study and a Double-blind, Placebo-controlled, Randomised Parallel Group 7-days Once Daily Repeat Dose Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral H1/H3 Dual Antagonist Compound in Healthy Male Subjects
This study is designed to assess the safety and tolerability of single, escalating oral doses and repeat oral doses (7 days, once daily) of GSK835726 in healthy male subjects
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
A double-blind, placebo controlled, randomized cross-over single dose escalation study and a double-blind, placebo controlled, randomised parallel group 7-days once daily repeat dose study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of oral H1/H3 dual antagonist compound in healthy male subjects
Studietype
Ingrijpend
Inschrijving (Werkelijk)
29
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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London, Verenigd Koninkrijk, NW10 7EW
- GSK Investigational Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 50 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Mannelijk
Beschrijving
Inclusion criteria:
- Male aged between 18 and 50 years inclusive.
- Body mass index within the range 19-29kg/m2 (inclusive), with weight range of 55kg-100kg (inclusive).
- Healthy (defined as individuals who are free from significant nasal, cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, malignancy, endocrine, neurological and psychiatric disease as determined by history, physical examination and screening investigations).
- Non-smoking status as verified by urinary cotinine levels below 300 ng/mL cotinine at the screening visit. This can include ex-smokers who have given up smoking for >1 year.
- Subjects to be entered in cohorts I and III only: Skin prick test reactivity to histamine of 3mm wheal > than saline control and some associated surrounding erythema.
- Subjects to be entered in cohorts I and III only: Negative skin prick test reactivity to saline control.
- The subject is able and willing to give written informed consent to take part in the study and is available to complete all study measurements.
- If sexually active, male subjects must agree to use a condom with spermicide during sexual intercourse, from the first dose of the study drug until 84 days after the last dose. In addition, female partners of male subjects, who are of childbearing potential, must use a reliable contraceptive method or they must refrain from sexual intercourse from the first dose of study medication until 84 days after the last dose. Reliable forms of contraception include an IUD, condom or diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants, contraceptive patches or a tubal ligation."
Exclusion criteria:
- As a result of the medical interview, physical examination or screening investigations, the Investigator or appropriately qualified designee considers the subject unfit for the study.
- The subject has a history of drug or any other allergy, which, in the opinion of the Investigator or appropriately qualified designee, contraindicates their participation, including known or suspected personal history or family history of adverse reactions or hypersensitivity to anti histamines.
- The subject has participated in a study with a new molecular entity during the previous 3 months or any other study during the previous 2 months.
- The subject regularly, or on average, drinks more than 21 units of alcohol a week or more than an average intake of 3 units per day (One unit = 125ml wine or 25ml spirits or 250ml normal strength lager).
- The subject is currently taking regular (or a course of) medication, prescribed (including all anti-allergy medication) or not (including over the counter medication or herbal remedies such as St Johns Wort). Paracetamol is an exception and will be permitted at daily doses of up to 4g following all doses of investigational product.
- The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen.
- The subject has tested positive for HIV.
- The subject has a positive drugs of abuse and alcohol test.
- Donation of blood (450 mL or more) within 2 months of screening.
- Donation during the study would result in >500mL of blood being donated over a 56 day period
Significant cardiac conduction abnormalities on two or more ECG tracings separated by at least 5 minutes at screening, including:
- QTc interval > 450 msec
- PR interval > 240 msec
- Evidence of second- or third- degree atrioventricular (AV) block
- Ventricular rate < 45 beats per minute (bpm) or > 100 bpm
- Pathological Q-waves (defined as Q-wave > 40 msec or depth greater than 0.4-0.5 mV)
- Evidence of ventricular pre-excitation
- Evidence of left axis deviation, non-specific intraventricular conduction delay (QRS duration > 120 msec), or complete left bundle branch block
- Subjects with Perennial Allergic Rhinitis (PAR) and Seasonal Allergic Rhinitis (SAR), unless subjects with SAR are asymptomatic and it is outside of the pollen season
- Subjects with dermatographism and other skin conditions that might interfere with the wheal and flare test.
- Subjects who are unable to comply with study procedures.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Subjects receiving treatment in cohort I
Eligible subjects will receive three single doses of GSK835726 and one single dose of placebo in cohort I.
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GSK835726 will be available in single dose and repeat dose formulations.
Placebo will be given to subjects.
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Experimenteel: Subjects receiving GSK835726 in cohort II
Eligible subjects will receive repeat doses of GSK835726 once daily for 7 days.
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GSK835726 will be available in single dose and repeat dose formulations.
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Placebo-vergelijker: Subjects receiving placebo in cohort II
Eligible subjects will receive repeat doses of placebo once daily for 7 days.
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Placebo will be given to subjects.
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Experimenteel: Subjects receiving treatment in cohort III
Eligible subjects will receive two single doses of GSK835726 and one single dose of placebo in cohort III.
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GSK835726 will be available in single dose and repeat dose formulations.
Placebo will be given to subjects.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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ECG monitoring during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts.
Tijdsspanne: during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts.
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during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts.
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Heart rate and blood pressure changes over 24 hours after dosing in single and repeat dose cohorts
Tijdsspanne: over 24 hours after dosing in single and repeat dose cohorts
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over 24 hours after dosing in single and repeat dose cohorts
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Change in plasma drug concentration (AUC, Cmax, t1/2, tmax)
Tijdsspanne: over 24 hours after dosing
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over 24 hours after dosing
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Changes in histamine-induced wheal and flare measurements
Tijdsspanne: over 24 hours after dosing
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over 24 hours after dosing
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Derived pharmacokinetic parameters for GSK835726 including area under the plasma drug concentration versus time curve (AUC(0-t), AUC(0-¥)), maximum observed plasma drug concentration (Cmax),
Tijdsspanne: over 24 hours after dosing
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over 24 hours after dosing
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time to maximum observed plasma drug concentration (tmax), apparent clearance (CL/F) and terminal half life (t1/2) following single and repeat oral dosing.
Tijdsspanne: over 24 hours after dosing
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over 24 hours after dosing
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
29 oktober 2007
Primaire voltooiing (Werkelijk)
3 mei 2008
Studie voltooiing (Werkelijk)
3 mei 2008
Studieregistratiedata
Eerst ingediend
18 januari 2008
Eerst ingediend dat voldeed aan de QC-criteria
18 januari 2008
Eerst geplaatst (Schatting)
31 januari 2008
Updates van studierecords
Laatste update geplaatst (Werkelijk)
21 augustus 2017
Laatste update ingediend die voldeed aan QC-criteria
16 augustus 2017
Laatst geverifieerd
1 augustus 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HH3110161
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Ja
Beschrijving IPD-plan
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Bestudeer gegevens/documenten
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Geannoteerd casusrapportformulier
Informatie-ID: HH3110161Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisch onderzoeksrapport
Informatie-ID: HH3110161Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Formulier geïnformeerde toestemming
Informatie-ID: HH3110161Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Gegevensset individuele deelnemers
Informatie-ID: HH3110161Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisch analyseplan
Informatie-ID: HH3110161Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Leerprotocool
Informatie-ID: HH3110161Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Specificatie gegevensset
Informatie-ID: HH3110161Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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