Last updated: 11/03/2018 09:04:49

EtOH Interaction Study

GSK study ID
106591
See study documents
Clinicaltrials.gov ID
NCT00887367
EudraCT ID
2008-003699-23
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A study to Investigate Potential Interactions between GSK598809 and Ethanol in Healthy Subjects
Trial description: This study will investigate the possible effects of alcohol in combination with GSK598809 on the central nervous system in 20 healthy male and female volunteers, between 18 and 65 years of age.
During 4 separate study periods subjects will receive the following treatment combinations: Alcohol + GSK598809, alcohol + placebo drug, placebo infusion + GSK598809, and placebo infusion + placebo drug. A placebo is a pill or liquid infusion which contains no drug or alcohol; it is a dummy version. Therefore it is administered in the same way that either the study drug or ethanol is depending on which placebo it is. All study drugs are administered in a random order and both the doctor and the participant are not aware of the treatment combination. However treatment combinations will be available at the end of the study or in case of an emergency. GSK598809 is administered orally and alcohol is administered per infusion. The duration of the infusion is 5 hours, during which approximately 75 grams of alcohol is infused, which is comparable to less than one bottle of wine.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Safety and tolerability: Vital sign measurement, 12 lead ECG and telemetry, safety laboratory sampling including prolactin and lipid measurements, Barnes Akathesia Scale (BAS), Simpson-Angus Scale (SAS) and Abnormal Involuntary Movement Scale (AIMS).

Timeframe: Screening: BAS, SAS and AIMS (as training only), 12 lead ECG, vital signs and clinical labs. All will be measured throughout dosing day (Day 1), day 2, 3: vital signs, day 4: vital signs, clinical labs, follow up: clinical labs, vital signs, 12 lead ECG

Pharmacokinetics: breath ethanol concentrations, blood ethanol concentrations, main pharmacokinetic parameters of GSK598809 and its metabolite (GSK685249) AUC∞, Cmax, Tmax and t½.

Timeframe: All will be measured throughout day 1, PK blood sampling for GSK598809 and GSK685249 will also be collected on Day 2, 3 and 4.

Pharmacodynamic: saccadic eye movements, smooth pursuit eye movements, body sway, adaptive tracking, Visual Verbal Learning Test (VVLT).

Timeframe: Saccadic eye movement, smooth pursuit eye movements, body sway and adaptive tracking measured at set intervals between 1.5hrs pre dose to 7.5hrs post dose. VVLT administered between 0.5hrs post dose to 3.5hrs post dose.

Secondary outcomes:

Pharmacodynamic/biomarker endpoints: saccadic eye movements, visual analogue scales (VAS B&L) according to Bond & Lader, Visual Analogue Scales for 'alcohol effects' (VAS 'Alcohol Effects').

Timeframe: Saccadic eye movements at time points as given above. VAS B&L and VAS 'Alcohol Effects' at following time points: -1.5, 0.5, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 7.5 hrs post dose.

Interventions:
  • Drug: GSK598809
  • Other: Ethanol
    • Enrollment:
    20
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Erik T. te Beek, Remco W.M. Zoethout, Massimo S.G. Bani, Anne Andorn, Laura Iavarone, Erica S. Klaassen, Paolo Fina, Joop M.A. van Gerven. Pharmacokinetics and central nervous system effects of the novel dopamine D3 receptor antagonist GSK598809 and intravenous infusion of alcohol at pseudo-steady state. [J. Psychopharmacology]. 2012;26(2):304-315.
    Medical condition
    Substance Dependence
    Product
    GSK598809
    Collaborators
    Not applicable
    Study date(s)
    September 2008 to December 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Generally healthy.
    • Occasional non-daily smokers.
    • Pregnant or breast feeding female.
    • Daily smoker.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Generally healthy.
    • Occasional non-daily smokers.
    • Willing to use appropriate contraception method.
    • Weight more than 50 kg.
    • BMI within the range 18
    • 30 kg/m2.
    Exclusion criteria:
    • Pregnant or breast feeding female.
    • Daily smoker.
    • Asthma or a history of asthma.
    • Abuse of drugs or alcohol.
    • Psychiatric illness.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    LEIDEN, Netherlands, 2333 CL
    Status
    Will Be Recruiting
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2008-03-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study 106591 can be found on the GSK Clinical Study Register.
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