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GSK1521498 Alcohol Interaction Study

This study has been completed.
Sponsor:
Collaborator:
University of Cambridge
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01366573
First received: May 12, 2011
Last updated: October 27, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Alcoholism
 Drug: GSK1521498
Other: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Pharmacokinetic interaction [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    AUC and Cmax of GSK1521498 and alcohol


Secondary Outcome Measures:
  • Safety: adverse events, vital signs, ECGs, physician/nurse observations, safety lab tests, mood assessments [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
  • Neurological assessments including Purdue Pegboard test [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: May 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK1521498 & alcohol
GSK1521498 20 mg and alcohol (0.5g/kg ethanol mixed with orange juice)
 Drug: GSK1521498
GSK1521498 20 mg administered with alcohol to determine PK/PD interactions
Experimental: GSK1521498 & orange juice
GSK1521498 20 mg and orange juice approximately matching alcoholic beverage for volume and colour
 Drug: GSK1521498
GSK1521498 20 mg administered with alcohol to determine PK/PD interactions
Experimental: Placebo & alcohol
Placebo and alcohol (0.5g/kg ethanol mixed with orange juice)
 Other: Placebo
Placebo
Placebo Comparator: Placebo & orange juice
Placebo and orange juice approximately matching alcoholic beverage for volume and colour
 Other: Placebo
Placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366573

Locations
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
GlaxoSmithKline
University of Cambridge
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01366573     History of Changes
Other Study ID Numbers: 115256
Study First Received: May 12, 2011
Last Updated: October 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Pharmacokinetics
mu-opioid receptors
Addiction
Pharmacodynamics
Alcohol

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013