GSK1521498 Alcohol Interaction Study

NCT01366573 | Completed Phase 1

• 1 other identifier: 115256
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcoholism

Keywords

Pharmacokinetics; mu-opioid receptors; Addiction; Pharmacodynamics; Alcohol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Safety: adverse events, vital signs, ECGs, physician/nurse observations, safety lab tests, mood assessments

  3 Months

• Neurological assessments including Purdue Pegboard test

  3 Months

Study Arms (4)

GSK1521498 & alcohol

EXPERIMENTAL

GSK1521498 20 mg and alcohol (0.5g/kg ethanol mixed with orange juice)

Drug: GSK1521498

GSK1521498 & orange juice

EXPERIMENTAL

GSK1521498 20 mg and orange juice approximately matching alcoholic beverage for volume and colour

Drug: GSK1521498

Placebo & alcohol

EXPERIMENTAL

Placebo and alcohol (0.5g/kg ethanol mixed with orange juice)

Other: Placebo

Placebo & orange juice

PLACEBO COMPARATOR

Placebo and orange juice approximately matching alcoholic beverage for volume and colour

Other: Placebo

Interventions

GSK1521498 DRUG

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

GSK1521498 & orange juice; GSK1521498 & alcohol

Placebo OTHER

Placebo

Placebo & alcohol; Placebo & orange juice

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• University of Cambridge: collaborator

Study Sites (1)

GSK Investigational Site

Austin, Texas, 78744, United States

Location

Related Links

• Results for study 115256 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Alcoholism; Behavior, Addictive

Interventions

N-((3,5-difluoro-3'-(1H-1,2,4-triazol-3-yl)-4-biphenylyl)methyl)-2,3-dihydro-1H-inden-2-amine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: June 6, 2011
• Study Start: May 13, 2011
• Primary Completion: September 16, 2011
• Study Completion: September 16, 2011
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)