A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects

• Change from pre-dose in DSST for Intent-to-Treat (ITTI subjects [ Time Frame: 2 and 6 hours post-dose ] [ Designated as safety issue: No ]
• Change from pre-dose in PVT for ITT subjects [ Time Frame: 2 and 6 hours post-dose ] [ Designated as safety issue: No ]
• Change from pre-dose in Buschke Selective Reminding Test (BSRT) for completed subjects [ Time Frame: 2 and 6 hours post-dose ] [ Designated as safety issue: No ]
• Change from pre-dose in BSRT for ITT subjects [ Time Frame: 2 and 6 hours post-dose ] [ Designated as safety issue: No ]
• Change from pre-dose in Stanford Sleepiness Scale (SSS) for completed subjects [ Time Frame: 2, 6, and 7.5 hours post-dose ] [ Designated as safety issue: No ]
• Change from pre-dose in SSS for ITT subjects [ Time Frame: 2, 6, and 7.5 hours post-dose ] [ Designated as safety issue: No ]
• Adverse events [ Time Frame: Throughout study duration ] [ Designated as safety issue: Yes ]
• Vital signs [ Time Frame: Throughout study duration ] [ Designated as safety issue: Yes ]
• Change from pre-dose in PVT for completed subjects [ Time Frame: 6 hours post-dose ] [ Designated as safety issue: No ]
• Change from pre-dose in Digit Symbol Substitution Test (DSST) for completed subjects [ Time Frame: 2 and 6 hours post-dose ] [ Designated as safety issue: No ]

The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and ethanol

• Drug: Placebo ethanol
  Matched placebo ethanol 0.4% in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint
• Drug: Ethanol
  Ethanol 0.7 g/kg in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint
• Drug: Placebo
  Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint
• Drug: Gabapentin
  Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint

• Placebo Comparator: A
  Interventions:

  • Drug: Placebo ethanol
  • Drug: Placebo
• Experimental: B
  Interventions:

  • Drug: Ethanol
  • Drug: Gabapentin
• Experimental: C
  Interventions:

  • Drug: Ethanol
  • Drug: Placebo
• Experimental: D
  Interventions:

  • Drug: Gabapentin
  • Drug: Placebo ethanol

Inclusion Criteria:

• Volunteers in good health aged 21 to 50 (inclusive) years who weigh 50 to 100 kg (110-220 lbs.)
• Experience with alcohol, defined as mild to moderate use of alcohol, ie, maximum of 14 alcoholic drinks per week

Exclusion Criteria:

• Recent history (within 2 years) of, or current treatment for, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition
• Recent history (within 2 years) of, or clinical evidence of significant unstable or uncontrolled respiratory (including asthma and congestive obstructive pulmonary disease), cardiovascular, gastrointestinal, hepatic, renal, endocrine, neurologic (including seizures), psychiatric or other chronic disease
• History of alcoholism or drug abuse; recreational drug use within the past 30 days; use of benzodiazepines, Ambien®, Sonata®, antidepressants or psychoactive medication within 30 days prior to screening; use of any other sedative, hypnotic, antihistamine, anticholinergic, melatonin, DHEA or herbal sleep/relaxation remedy within 7 days prior to screening