CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 5 enrolled
Drug / intervention
Saracatinibdrug
Likely dose
Saracatinib 125 mg orally once daily for 8-11 daysAI-extracted
Key inclusion· 4
  • Age 21-50 years
  • Social drinkers consuming 1-6 standard drinks per week with ≤5 binge episodes in past year
  • BMI 19-30
  • Able to read English at 6th grade level and complete study evaluations
Key exclusion· 8
  • Current DSM-V alcohol or substance abuse/dependence (except nicotine)
  • Positive drug screen after intake for opiates, cocaine, marijuana, benzodiazepines, or barbiturates
  • Regular use of psychoactive drugs including anxiolytics and antidepressants
  • Psychotic or severely psychiatrically disabled

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02732587
NCT02732587Phase 1Completed

A Phase 1 Study Investigating the Interactions of AZD0530 With Alcohol in Social Drinkers

Yale University·interventional·Posted Apr 8, 2016·Updated Jan 14, 2020

In Brief

A Phase 1 clinical trial evaluating Saracatinib for Alcohol Drinking. Completed, enrolled 5 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 8, 2016
Enrollment StartNov 1, 2015
Primary CompletionMar 15, 2016
Study CompletionMar 23, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.2 years ago

Interventions

Saracatinibdrug

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