Mavoglurant in Alcohol Drinking

The purpose of this alcohol-interaction pilot study is to provide information on the effect
of mavoglurant on the pharmacokinetics of alcohol and on alcohol responses, including
stimulation, sedation, intoxication, body sway and physiological responses. The investigators
propose to test the effects of 200 mg mavoglurant versus placebo on alcohol related
responses. This is a between subjects double blind randomized design in which the
investigators plan to run 14 subjects to obtain 10 completers.

Subjects will participate in two lab sessions, one prior to taking medication and one
following 8-11 days of mavoglurant/placebo. During each session, participants will receive
successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels
to 80 mg/dl; this dose was chosen because this is close to the legal limit of intoxication
and to the peak BAC the investigators have observed in prior research studies. Subjects will
be monitored throughout the lab session and will receive a phone call two days following the
2nd lab session and a follow-up appointment one week after the 2nd lab session to assess any
remaining side effects from the medication.

Inclusion Criteria:

1. Ages 21-50

2. Able to read English at 6th grade level or higher and to complete study evaluations

3. Social drinkers

4. Willing to abstain from drinking alcohol during the outpatient study medication
treatment period

Exclusion Criteria:

1. Seeking treatment for alcohol drinking

2. Current DSM-V criteria for any other substances, other than alcohol or nicotine.

3. Positive test results at any appointments after the initial intake appointment on
urine drug screens conducted for opiates, cocaine, marijuana, benzodiazepines and/or
barbiturates.

4. Regular use of psychoactive drugs including anxiolytics and antidepressants.

5. Psychotic or otherwise severely psychiatrically disabled.

6. Any medical conditions (including hepatic and renal impairment) that would
contraindicate the consumption of alcohol or administration of mavoglurant.

7. History of neurological trauma or disease, delirium, or hallucinations, or any
significant systemic illness or unstable medical condition.

8. Women who are pregnant, nursing, or refuse to use a reliable method of birth control.
Urine pregnancy tests will be completed at intake and prior to administration of
alcohol at each lab session.

9. Subjects who report disliking spirits will be excluded because hard liquor will be
provided during the alcohol administration.

10. Subjects who have taken any investigational drug and/or participated in another study
which involves additive blood sampling and/or interventional measures that would be
considered excessive in combination with the current protocol within 4 weeks
immediately preceding admission to the treatment period.

11. Subjects who report any daily drug use during the 30 days prior to randomization for
the following: anxiolytics, beta blockers, central nervous system stimulants,
hypnotics, non-therapeutic doses of neuroleptics and antidepressants, drugs with
psychotropic activity or drugs which cause excessive sedation.

12. Subjects who have donated blood within the past six weeks.

13. Subjects who have taken, within the prior 14 days, the following strong inhibitors or
inducers of CYP1A, CYP2C, and CYP3A and CYP3A4: ciprofloxacin, enoxacin, fluvoxamine;
gemfibrozil; fluconazole, fluvoxamine, ticlopidine; boceprevir, clarithromycin,
conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole,
lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir,
saquinavir, telaprevir, telithromycin, voriconazole; bupropion, fluoxetine,
paroxetine, quinidine; avasimibe, carbamazepine, phenytoin, rifampin, and St. John's
wort. We will also exclude individuals who have taken, within 14 days, the following
moderate inhibitors and inducers of CYP3A: Amprenavir, aprepitant, atazanavir,
ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole,
fosamprenavir, imatinib, and verapamil; and bosentan, efavirenz, etravirine,
modafinil, and nafcillin.

14. Current use of warfarin.

15. Use of any medications that are contraindicated with mavoglurant and alcohol.

16. AST, ALT, total bilirubin >1.5 times upper normal; serum creatinine, >2 times upper
normal limit, total bilirubin>1.5 times ULN; Serum creatinine >2.0 times ULN.