Trial Outcomes & Findings for Investigating the Interactions of AZD0530 With Alcohol in Social Drinkers (NCT NCT02732587)
NCT ID: NCT02732587
Last Updated: 2020-01-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
5 participants
Primary outcome timeframe
8 days
Results posted on
2020-01-14
Participant Flow
Subjects were recruited online via craigslist.com and through local flyering
Participant milestones
| Measure |
125 mg Saracatinib
. Subjects participated in two inpatient alcohol administration lab sessions, a baseline session and a second session after taking 125 mg of AZD0530 for 8 outpatient days. During the outpatient drug administration phase subjects came in daily to receive their medication and at that time adverse events were assessed. Subject administration of daily medication dose was observed. The baseline session allowed participants to familiarize themselves with the procedures and provide us with a medication-free comparison for the effects of AZD0530 within the same subjects. During each lab session, subjects received six successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80 mg/dl.
|
|---|---|
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Overall Study
STARTED
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5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigating the Interactions of AZD0530 With Alcohol in Social Drinkers
Baseline characteristics by cohort
| Measure |
125 mg Saracatinib
n=5 Participants
125 mg Saracatinib once daily for 8-11 days
Saracatinib: Subjects will receive 125 mg Saracatinib for 8-11 days followed by an alcohol interaction lab session
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|---|---|
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Age, Continuous
|
26 years
STANDARD_DEVIATION 2.24 • n=39 Participants
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Sex: Female, Male
Female
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3 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
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2 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
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Region of Enrollment
United States
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5 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 8 daysNumber 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.
Outcome measures
| Measure |
125 mg Saracatinib
n=5 Participants
Subjects participated in two inpatient alcohol administration lab sessions, a baseline session and a second session after taking 125 mg of AZD0530 for 8 outpatient days. During the outpatient drug administration phase subjects came in daily to receive their medication and at that time adverse events were assessed. Subject administration of daily medication dose was observed. The baseline session allowed participants to familiarize themselves with the procedures and provide us with a medication-free comparison for the effects of AZD0530 within the same subjects. During each lab session, subjects received six successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80 mg/dl.
|
|---|---|
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Safety/Tolerability of Study Medication.
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0 participants
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Adverse Events
125 mg Saracatinib
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
125 mg Saracatinib
n=5 participants at risk
Subjects participated in two inpatient alcohol administration lab sessions, a baseline session and a second session after taking 125 mg of AZD0530 for 8 outpatient days. During the outpatient drug administration phase subjects came in daily to receive their medication and at that time adverse events were assessed. Subject administration of daily medication dose was observed. The baseline session allowed participants to familiarize themselves with the procedures and provide us with a medication-free comparison for the effects of AZD0530 within the same subjects. During each lab session, subjects received six successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80 mg/dl.
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|---|---|
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General disorders
Sleepy
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20.0%
1/5 • Number of events 1 • 5 months
AE's were collected using the SAFTEE: Levine J., \& Schooler N.R. (1986). SAFTEE: a technique for the systematic assessment of side effects in clinical trials. Psychopharmacology Bulletin, 22(2):343-81.
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Gastrointestinal disorders
Decrease in appetite
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20.0%
1/5 • Number of events 1 • 5 months
AE's were collected using the SAFTEE: Levine J., \& Schooler N.R. (1986). SAFTEE: a technique for the systematic assessment of side effects in clinical trials. Psychopharmacology Bulletin, 22(2):343-81.
|
|
General disorders
headache
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20.0%
1/5 • Number of events 1 • 5 months
AE's were collected using the SAFTEE: Levine J., \& Schooler N.R. (1986). SAFTEE: a technique for the systematic assessment of side effects in clinical trials. Psychopharmacology Bulletin, 22(2):343-81.
|
|
Eye disorders
eye twitch (right)
|
20.0%
1/5 • Number of events 1 • 5 months
AE's were collected using the SAFTEE: Levine J., \& Schooler N.R. (1986). SAFTEE: a technique for the systematic assessment of side effects in clinical trials. Psychopharmacology Bulletin, 22(2):343-81.
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Additional Information
Dr Suchitra Krishnan-Sarin
Yale University Dept of Psychiatry
Phone: 203-974-7595
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place