Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Pharmacokinetic interaction
Timeframe: 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:
Safety: adverse events, vital signs, ECGs, physician/nurse observations, safety lab tests, mood assessments
Timeframe: 3 Months
Neurological assessments including Purdue Pegboard test
Timeframe: 3 Months
Interventions:
Drug: GSK1521498
Other: Placebo
Enrollment:
1
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Nathan PJ, Bush MA, Tao WX, Koch A, Davies KM, Maltby K, O'Neill BV, Napolitano A, Skeggs, A, Brooke AC, Richards DB, Williams PM, Bullmore ET.Multiple-Dose Safety, Pharmacokinetics, and Pharmacodynamics of the µ-Opioid Receptor Inverse Agonist GSK1521498 .J Clin Pharmacol.2013;53(10):1078-1090
Medical condition
Alcoholism
Product
GSK1521498
Collaborators
University of Cambridge
Study date(s)
May 2011 to September 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
21 - 55 years
Accepts healthy volunteers
Yes
- healthy male or female between 21 and 55 years of age inclusive.
- within 20% normal weight for height and body build.
- A positive test for HIV, Hep B or Hep C.
- Current or chronic history of liver disease.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2011-16-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 115256 can be found on the GSK Clinical Study Register.
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