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GSK1521498 Alcohol Interaction Study

18. juli 2017 opdateret af: GlaxoSmithKline

A Randomised, Double-Blind, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics and Pharmacodynamics of GSK1521498 in Healthy Subjects

The aim of the study is to assess the safety and tolerability of GSK1521498 in combination with alcohol and to determine the amount of GSK1521498 and alcohol in your blood after you have been given these together. The study will also determine whether GSK1521498 will have an effect on alcohol liking and consumption.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study is to test a new drug which may be used for treating alcohol addiction. The drug works by inhibiting the effects of messenger molecules called opioids. These opioids are naturally produced within the human body, and are involved in controlling how much alcohol we drink and the pleasure we get from drinking alcohol. We believe that GSK1521498 might be effective in the treatment of alcohol addiction because it is well known that drugs working on similar binding sites in the brain reduce the pleasure we get from drinking alcohol. As alcohol can effect the way that a drug is metabolised in the body, The investigators need to determine that it is safe to take GSK1521498 in combination with alcohol. and to determine the amount of GSK1521498 and alcohol in your blood after you have been given these together. The study will also determine whether GSK1521498 will have an effect on alcohol liking and consumption.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Texas
      • Austin, Texas, Forenede Stater, 78744
        • GSK Investigational Site

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

21 år til 55 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • healthy male or female between 21 and 55 years of age inclusive.
  • within 20% normal weight for height and body build.
  • A female subject of child-bearing potential must use one of the contraception methods listed in the protocol prior to the start of the study until at least 14 days after receiving the last dose of study medication.
  • Male subjects must agree to use one of the contraception methods listed in the protocol from the time of the first dose of study medication until at least 5 days after receiving the last dose of study medication.
  • History of regular alcohol consumption within 6 months of study.
  • No recent changes in patterns of alcohol consumption.
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

  • A positive test for HIV, Hep B or Hep C.
  • Current or chronic history of liver disease.
  • Current or chronic history of neurological disorders.
  • Subjects with previous or current psychiatric history.
  • Past history of DSM-IV alcohol dependence or abuse.
  • Binge drinking more than once a week (>5 standard drinks in one session is a binge).
  • Currently trying to quit alcohol.
  • Positive urine screen for amphetamines, barbiturates, cocaine, opiates, cannabinoids or bezodiazepines at screening.
  • Regular consumption of >450mg caffeine per day (an average cup contains about 75mg).
  • Heavy smokers, defined as those who smoke >10 cigarettes a day. Also those who cannot abstain during the admission period.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first dose of study medication.
  • Pregnant or lactating females.
  • QTcB or QTcF >450msec.
  • Participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product.
  • Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56 day period.

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: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: GSK1521498 & alcohol
GSK1521498 20 mg and alcohol (0.5g/kg ethanol mixed with orange juice)
GSK1521498 20 mg administered with alcohol to determine PK/PD interactions
Eksperimentel: GSK1521498 & orange juice
GSK1521498 20 mg and orange juice approximately matching alcoholic beverage for volume and colour
GSK1521498 20 mg administered with alcohol to determine PK/PD interactions
Eksperimentel: Placebo & alcohol
Placebo and alcohol (0.5g/kg ethanol mixed with orange juice)
Placebo
Placebo komparator: Placebo & orange juice
Placebo and orange juice approximately matching alcoholic beverage for volume and colour
Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pharmacokinetic interaction
Tidsramme: GSK1521498 PK sampling; pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 13, 24, 48 and 72 hr post-dose.
AUC and Cmax of GSK1521498 and alcohol
GSK1521498 PK sampling; pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 13, 24, 48 and 72 hr post-dose.

Sekundære resultatmål

Resultatmål
Tidsramme
Safety: adverse events, vital signs, ECGs, physician/nurse observations, safety lab tests, mood assessments
Tidsramme: 3 Months
3 Months
Neurological assessments including Purdue Pegboard test
Tidsramme: 3 Months
3 Months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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 (Faktiske)

13. maj 2011

Primær færdiggørelse (Faktiske)

16. september 2011

Studieafslutning (Faktiske)

16. september 2011

Datoer for studieregistrering

Først indsendt

12. maj 2011

Først indsendt, der opfyldte QC-kriterier

2. juni 2011

Først opslået (Skøn)

6. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juli 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiedata/dokumenter

  1. Individuelt deltagerdatasæt
    Informations-id: 115256
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistisk analyseplan
    Informations-id: 115256
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Klinisk undersøgelsesrapport
    Informations-id: 115256
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Datasætspecifikation
    Informations-id: 115256
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Annoteret sagsbetænkningsformular
    Informations-id: 115256
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Formular til informeret samtykke
    Informations-id: 115256
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Studieprotokol
    Informations-id: 115256
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Placebo

3
Abonner