GSK1521498 Alcohol Interaction Study

• Status: Completed
• Trial end date: 2011-09-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Collaborator: University of Cambridge
• Treatments: Ethanol

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.