GSK1521498 Alcohol Interaction Study

Alcoholism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366573
• Other study ID #: 115256
• Status: Completed
• Phase: Phase 1
• First received: May 12, 2011
• Last updated: July 18, 2017
• Start date: May 13, 2011
• Est. completion date: September 16, 2011

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: September 16, 2011
• Est. primary completion date: September 16, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• GSK1521498
GSK1521498 20 mg administered with alcohol to determine PK/PD interactions

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	University of Cambridge

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety: adverse events, vital signs, ECGs, physician/nurse observations, safety lab tests, mood assessments		3 Months
Secondary	Neurological assessments including Purdue Pegboard test		3 Months

External 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.
•   Results for study 115256 can be found on the GSK Clinical Study Register.