Investigating the Interactions of AZD0530 With Alcohol in Social Drinkers

• Status: Completed
• Trial end date: 2016-03-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this alcohol-interaction pilot study is to provide information on the effect of AZD0530 (Saracatinib) 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 a single dose of AZD0530 (125 mg) on alcohol related responses. This is a within subjects open label study in which the investigators plan to run 8 subjects to obtain 5 completers.

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

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Saracatinib

Criteria

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 consuming 1- 6 standard alcoholic drinks per week and having engaged in at least one and no more than 5 binge drinking episodes in the past year.

4. BMI 19-30

Exclusion Criteria:

1. Current DSM-V abuse or dependence criteria for alcohol, dependence criteria for other substances, other than nicotine.

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

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

4. Psychotic or otherwise severely psychiatrically disabled.

5. Medical conditions that would contraindicate the consumption of alcohol.

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

7. 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.

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

9. 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.

10. 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.

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

12. Current use (within 30 days of screening) of specific psychoactive medications (e.g., typical neuroleptics, narcotic analgesics, antiparkinsonian medications, systemic corticosteroids, or medications with significant central anticholinergic activity, etc.). Current use of warfarin.

13. Current use of the following medications (CYP3A4 substrates whose metabolism may be slowed by AZD0530): carbamazepine, colchicine, cyclosporine, disopyramide, fluticasone, quinidine, vinblastine, vincristine, nifedipine. Patients taking sildenafil, tadalafil, and vardenafil will be advised to stop taking these medications for the duration of the trial. Patients cannot take the following drugs which inhibit the CYP3A4 isoenzyme: cimetidine, cyclosporine, danazol, fluconazole, grapefruit juice, HIV protease inhibitors, itraconazole, ketoconazole, macrolides, miconazole, nefazodone, omeprazole, ritonavir, and verapamil.

14. Neutropenia defined as absolute neutrophils count of <1,500/microliter.

15. Thrombocytopenia defined as platelet count <100x103/microliter.

16. Liver function tests (AST, ALT, total bilirubin) >1.5 times upper limit of normal (ULN); serum creatinine, >2 times ULN, total bilirubin>1.5 times ULN; Serum creatinine >2.0 times ULN.

17. History of interstitial lung disease.