GSK1521498 Alcohol Interaction Study
18. juli 2017 oppdatert av: 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.
Studieoversikt
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
1
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Texas
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Austin, Texas, Forente stater, 78744
- GSK Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år til 55 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: GSK1521498 & alcohol
GSK1521498 20 mg and alcohol (0.5g/kg ethanol mixed with orange juice)
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GSK1521498 20 mg administered with alcohol to determine PK/PD interactions
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Eksperimentell: GSK1521498 & orange juice
GSK1521498 20 mg and orange juice approximately matching alcoholic beverage for volume and colour
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GSK1521498 20 mg administered with alcohol to determine PK/PD interactions
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Eksperimentell: Placebo & alcohol
Placebo and alcohol (0.5g/kg ethanol mixed with orange juice)
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Placebo
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Placebo komparator: Placebo & orange juice
Placebo and orange juice approximately matching alcoholic beverage for volume and colour
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Placebo
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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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.
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AUC and Cmax of GSK1521498 and alcohol
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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.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Safety: adverse events, vital signs, ECGs, physician/nurse observations, safety lab tests, mood assessments
Tidsramme: 3 Months
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3 Months
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Neurological assessments including Purdue Pegboard test
Tidsramme: 3 Months
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3 Months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
13. mai 2011
Primær fullføring (Faktiske)
16. september 2011
Studiet fullført (Faktiske)
16. september 2011
Datoer for studieregistrering
Først innsendt
12. mai 2011
Først innsendt som oppfylte QC-kriteriene
2. juni 2011
Først lagt ut (Anslag)
6. juni 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. juli 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. juli 2017
Sist bekreftet
1. juli 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 115256
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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
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Datasett for individuell deltaker
Informasjonsidentifikator: 115256Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisk analyseplan
Informasjonsidentifikator: 115256Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk studierapport
Informasjonsidentifikator: 115256Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasettspesifikasjon
Informasjonsidentifikator: 115256Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Annotert saksrapportskjema
Informasjonsidentifikator: 115256Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Skjema for informert samtykke
Informasjonsidentifikator: 115256Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informasjonsidentifikator: 115256Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .