GSK1521498 Alcohol Interaction Study

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.

Study Overview

• Status: Completed
• Conditions: Alcoholism
• Intervention / Treatment: Other: Placebo; Drug: GSK1521498

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic interaction	AUC and Cmax of GSK1521498 and alcohol	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.

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: adverse events, vital signs, ECGs, physician/nurse observations, safety lab tests, mood assessments	3 Months
Neurological assessments including Purdue Pegboard test	3 Months

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: University of Cambridge

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2011
• Primary Completion (Actual): September 16, 2011
• Study Completion (Actual): September 16, 2011

Study Registration Dates

• First Submitted: May 12, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimate): June 6, 2011

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Alcohol; Addiction; Pharmacodynamics; mu-opioid receptors
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: 115256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: 115256
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Statistical Analysis Plan
   Information identifier: 115256
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Clinical Study Report
   Information identifier: 115256
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: 115256
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Annotated Case Report Form
   Information identifier: 115256
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Informed Consent Form
   Information identifier: 115256
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Study Protocol
   Information identifier: 115256
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register