Investigating the Interactions of AZD0530 With Alcohol in Social Drinkers

NCT02732587 | Completed Phase 1 Results DMC

• 2 other identifiers: 0602001068-2P50AA012870
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Drinking

Outcome Measures

Primary Outcomes (1)

• Safety/Tolerability of Study Medication.

  Number of subjects - taking 125 mg of AZD0530 (saracatinib) over 8 days - in an alcohol drinking paradigm raising blood alcohol to 80 mg/dl who had any concerning changes in physiological or behavioral outcome measures.

  8 days

Study Arms (1)

125 mg Saracatinib

EXPERIMENTAL

125 mg Saracatinib once daily for 8-11 days

Drug: Saracatinib

Interventions

Saracatinib DRUG

Subjects will receive 125 mg Saracatinib for 8-11 days followed by an alcohol interaction lab session

Also known as: AZD0530

125 mg Saracatinib

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 21-50
• Able to read English at 6th grade level or higher and to complete study evaluations
• 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.
• BMI 19-30

You may not qualify if:

• Current DSM-V abuse or dependence criteria for alcohol, dependence criteria for other substances, other than nicotine.
• Positive test results at any appointments after the initial intake appointment on urine drug screens conducted for opiates, cocaine, marijuana, benzodiazepines and/or barbiturates.
• Regular use of psychoactive drugs including anxiolytics and antidepressants.
• Psychotic or otherwise severely psychiatrically disabled.
• Medical conditions that would contraindicate the consumption of alcohol.
• History of neurological trauma or disease, delirium, or hallucinations, or any significant systemic illness or unstable medical condition.
• 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.
• Subjects who report disliking spirits will be excluded because hard liquor will be provided during the alcohol administration.
• 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.
• 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.
• Subjects who have donated blood within the past six weeks.
• 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.
• 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.
• Neutropenia defined as absolute neutrophils count of \<1,500/microliter.
• Thrombocytopenia defined as platelet count \<100x103/microliter.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

CMHC, Substance Abuse Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

saracatinib

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Results Point of Contact

• Title: Dr Suchitra Krishnan-Sarin
• Organization: Yale University Dept of Psychiatry

suchitra.krishnan-sarin@yale.edu

203-974-7595

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: April 8, 2016
• Study Start: November 1, 2015
• Primary Completion: March 15, 2016
• Study Completion: March 23, 2016
• Last Updated: January 14, 2020
• Results First Posted: January 14, 2020

Record last verified: 2020-01

Locations

US (1)