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GSK2018682 FTIH in Healthy Volunteers (P1A114070)

7 juni 2017 uppdaterad av: GlaxoSmithKline

A Single-blind, Placebo-controlled, Two Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of GSK2018682 in Healthy Volunteers

This protocol describes the first administration of GSK2018682 to humans. The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of GSK2018682. The study will also provide preliminary evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte counts.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

This protocol describes the first administration of GSK2018682 to humans. The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of GSK2018682. The study will also provide preliminary evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte counts.

Studietyp

Interventionell

Inskrivning (Faktisk)

27

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • New South Wales
      • Randwick, New South Wales, Australien, 2031
        • GSK Investigational Site
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • GSK Investigational Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 55 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • 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 significantly 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. Subjects with lymphocyte counts outside the normal range should always be excluded from enrollment
  • BMI within the range 19 - 28 kg/m2 (inclusive).

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.
  • History of regular alcohol consumption
  • Subjects with a history of, or examination suspicious for, skin cancer(s) including melanoma, basal cell or squamous cell carcinoma.
  • Systolic blood pressure less than 95 mmHg or greater than 140 mmHg, or diastolic blood pressure less than or equal to 50 mmHg or greater than or equal to 95 mmHg.
  • Symptomatic reduction in blood pressure after orthostatic challenge.
  • Subjects with resting heart rate less than 45 beats per minute or greater than 90 beats per minute

Other criteria may apply as defined by the clinical protocol.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Part A
Part A will be used to confirm the prediction of GSK2018682 PK, assess its effects on lymphocytes, and monitor its safety profile in a single cohort (Cohort 1). Cohort 1 will consist of 4 subjects and explore 4 doses of GSK2018682 in 4 study sessions. In each session, three subjects will receive GSK2018682 and one subject will receive placebo. Thus, when the cohort completes, each subject will receive placebo and 3 doses of GSK2018682.
GSK2018682
Matchad placebo
Experimentell: Part B
Part B will explore doses to refine the dose-response curve of GSK2018682 on lymphocyte suppression, as allowed by stopping criteria, in 1 or 2 cohorts of up to 15 subjects (Cohort 2 and Cohort 3). In Part B, up to six single ascending doses of GSK2018682 and one dose of placebo will be investigated in up to 8 sessions.
GSK2018682
Matchad placebo

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To investigate the safety and tolerability of single escalating oral doses of GSK2018682
Tidsram: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
Adverse event and safety lab monitoring
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
To investigate effects of GSK2018682 on heart rate and blood pressure
Tidsram: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
12 lead ECG and telemetry monitoring plus vital signs (systolic and diastolic blood blood pressures), heart rate, respiratory rate and temperature
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
To investigate the pharmacokinetics of single doses of GSK2018682
Tidsram: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
Peak blood concentration, time of peak blood concentration, oral clearance, half life and AUC
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
Evaluate the effect of single escalating oral doses of GSK2018682 on lymphocytes (totals plus subsets)
Tidsram: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
Reduction from baseline in lymphocyte counts obtained at different time points after dosing and at different dose levels
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

21 maj 2010

Primärt slutförande (Faktisk)

20 december 2010

Avslutad studie (Faktisk)

20 december 2010

Studieregistreringsdatum

Först inskickad

14 april 2011

Först inskickad som uppfyllde QC-kriterierna

30 juni 2011

Första postat (Uppskatta)

4 juli 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 juni 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 juni 2017

Senast verifierad

1 juni 2017

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

IPD-planbeskrivning

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

Studiedata/dokument

  1. Datauppsättning för individuella deltagare
    Informationsidentifierare: 114070
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Klinisk studierapport
    Informationsidentifierare: 114070
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Studieprotokoll
    Informationsidentifierare: 114070
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistisk analysplan
    Informationsidentifierare: 114070
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Annoterad fallrapportformulär
    Informationsidentifierare: 114070
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Informerat samtycke
    Informationsidentifierare: 114070
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Datauppsättningsspecifikation
    Informationsidentifierare: 114070
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Multipel skleros

Kliniska prövningar på GSK2018682

3
Prenumerera