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A Human Volunteer Study Investigating Single Oral Doses of GSK598809 in Otherwise Healthy Smokers

1. august 2017 opdateret af: GlaxoSmithKline

A Placebo-controlled, Single-blind, Randomised, Human Volunteer Study Investigating the Tolerability and Pharmacokinetics of Escalating Single Oral Doses (75mg and Above) of GSK598809 in Otherwise Healthy Smokers

Study to investigate the safety, tolerability and pharmacokinetics of GSK598809 in otherwise healthy volunteers. This study is required because this drug is being developed for the treatment of nicotine dependence. It is important to evaluate how this drug interacts in healthy smokers. The study is planned to consist of a single part, with 4 dosing periods. Subjects will receive 3 escalating doses of GSK598809 and 1 dose of placebo. There will be at least 1 week of wash out between doses. In each dosing period 14 subjects will receive escalating doses and 4 subjects will receive placebo. The actual doses used will be determined based on the safety/ tolerability and pharmacokinetics during the previous dose. It is expected that the duration of this study will be approximately 10 weeks.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Tyskland
      • Berlin, Tyskland, 13251
        • 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

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion:

  • A healthy man or woman
  • 18 - 50 years old
  • Neither too fat, nor too thin
  • Female subjects must use an acceptable method of contraception from the first dose of study medication until 90 days following the final follow-up visit.
  • Female subjects must not be breast feeding and should not have been breast feeding for a month.
  • Male subjects must agree to use an acceptable method of contraception from the first dose of study medication until 90 days following the final follow-up.
  • Subjects need to smoke 20 - 40 cigarettes a day inclusive for at least the past year and to not have tried to quit in the 3 months before the start of the study.

Exclusion:

  • Any current medical or psychiatric illness
  • Any history of chronic medical or psychiatric illnesses
  • Previous or current alcohol or drug abuse/dependence including nicotine
  • Personal or family history of prolonged QTc syndrome

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: Subjects receiving treatment sequence ABCD
Subjects will receive treatment sequence ABCD; A= placebo, B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, and D = GSK598809 dose 3.
Medicin: GSK598809
GSK598809 capsules will be available with dose strengths of 5 milligrams and 25 milligrams, administered orally with water.
Medicin: Placebo
Placebo capsules will be administered orally with water.
Eksperimentel: Subjects receiving treatment sequence BACD
Subjects will receive treatment sequence BACD; B= GSK598809 dose 1 (75 milligrams), A= placebo, C = GSK598809 dose 2 and D = GSK598809 dose 3
Medicin: GSK598809
GSK598809 capsules will be available with dose strengths of 5 milligrams and 25 milligrams, administered orally with water.
Medicin: Placebo
Placebo capsules will be administered orally with water.
Eksperimentel: Subjects receiving treatment sequence BCAD
Subjects will receive treatment sequence BCAD; B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, A= placebo and D = GSK598809 dose 3.
Medicin: GSK598809
GSK598809 capsules will be available with dose strengths of 5 milligrams and 25 milligrams, administered orally with water.
Medicin: Placebo
Placebo capsules will be administered orally with water.
Eksperimentel: Subjects receiving treatment sequence BCDA
Subjects will receive treatment sequence BCDA; B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, D = GSK598809 dose 3 and A= placebo.
Medicin: GSK598809
GSK598809 capsules will be available with dose strengths of 5 milligrams and 25 milligrams, administered orally with water.
Medicin: Placebo
Placebo capsules will be administered orally with water.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Safety and tolerability: Clinical labs, cardiovascular variables, vital signs, adverse events over 48 hours post dosing and at follow up. Psychological assessment and movement scales will be monitored. Blood Sampling over 48 hours.
Tidsramme: 48 hours post dose
48 hours post dose

Sekundære resultatmål

Resultatmål
Tidsramme
Cigarette craving assessed over 24 hours around dosing. Cigarette Consumption to be monitored during the whole study.Withdrawal from nicotine assessed during first four hours of dosing. Cognition/ impulsivity assessed over 24 hours after dosing.
Tidsramme: 24 hours
24 hours

Samarbejdspartnere og efterforskere

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

Sponsor

GlaxoSmithKline

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)

9. juni 2008

Primær færdiggørelse (Faktiske)

19. august 2008

Studieafslutning (Faktiske)

19. august 2008

Datoer for studieregistrering

Først indsendt

1. august 2008

Først indsendt, der opfyldte QC-kriterier

1. august 2008

Først opslået (Skøn)

5. august 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. august 2017

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DAN111282

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 .

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