Study Summary
This trial will study how alcohol interacts with the drug PT150 given to people who have experience with alcohol.
Eligible Conditions
- Alcohol Interaction Treatment
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 10 Secondary · Reporting Duration: An ECG measurement is taken once on day 1 prior to ethanol and PT150 exposure, followed by measurements on days 2, 5, 6, 7, 8, and 9 (all post-PT150 exposure measurements).
Adverse events are reported throughout the study, from enrollment to study completion
Difference in the number and severity of adverse events
Day 2
Change in ECG abnormalities
Day 9
Difference in diastolic blood pressure
Day 9
Difference in heart rate
Day 9
Difference in systolic blood pressure
Day 5
Change in severity of alcohol withdrawal symptom severity as measured on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar)
Day 7
Difference in area under the concentration-time curve of PT150 (AUCPT150)
Difference in maximum concentration of PT150 (CmaxPT150)
Difference in time of maximum concentration of PT150 (tmaxPT150)
Difference in time of one-half the maximum concentration of PT150 (t1/2PT150)
Day 7
Difference in the area under the concentration-time curve of ethanol (AUCEtOH)
Difference in the maximum concentration of ethanol (CmaxEtOH)
Difference in the time of one-half of the maximum concentration of ethanol (t1/2EtOH)
Difference in time of maximum concentration of ethanol (tmaxEtOH)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
PT150 with alcohol consumption
1 of 1
Experimental Treatment
10 Total Participants · 1 Treatment Group
Primary Treatment: PT150 with alcohol consumption · No Placebo Group · Phase 1
PT150 with alcohol consumptionExperimental Group · 2 Interventions: PT150, Beverage · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ORG-34517
Not yet FDA approved
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: an ecg measurement is taken once on day 1 prior to ethanol and pt150 exposure, followed by measurements on days 2, 5, 6, 7, 8, and 9 (all post-pt150 exposure measurements).
Who is running the clinical trial?
Pop Test Oncology LLCLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Congressionally Directed Medical Research ProgramsFED
35 Previous Clinical Trials
5,744 Total Patients Enrolled
Baylor College of MedicineOTHER
919 Previous Clinical Trials
5,986,408 Total Patients Enrolled
Michael E. DeBakey VA Medical CenterFED
62 Previous Clinical Trials
15,529 Total Patients Enrolled
Pharmacotherapies for Alcohol and Substance Use Disorders AllianceOTHER
5 Previous Clinical Trials
230 Total Patients Enrolled
Christopher Verrico, PhDPrincipal InvestigatorMichael E. DeBakey Veterans Affairs Medical Center
Eligibility Criteria
Age 21 - 64 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:If your blood tests results are not within the acceptable limits noted in the protocol, you may have to have the test again.
The patient should have normal heart rate (between 50 and 100 beats per minute), normal blood pressure (between 90 and 140 millimeters of mercury), and a normal ECG that shows normal sinus rhythm, normal conduction, normal QTc, and no significant arrhythmias.
To be considered for medical detoxification, a person must have a score of 10 or less on the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar) and have a blood alcohol level of 0.00% or less.
The participant must be willing to comply with all study procedures and be available for the duration of the study.
Women must either not be able to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or using a non-hormonal, medically accepted form of contraception during the study and for at least 2 weeks after study completion, with or without additional hormonal contraception
however, if the urine pregnancy test on day 7 is positive, the participant is discontinued from the study
Are willing and able to comply with the study schedule and protocol;
Do not have a history of significant allergic reactions to insect bites;
Do not have a history of significant adverse reactions to medications;
Do not have a history of significant illness or significant ongoing health problems;
Do not have a history of significant mental health problems
Can prove they are over the age of 18 and can give their full name and date of birth.
Please sign and date this form to indicate that you have been provided with information about the study and that you consent to participate.
have health insurance
We are looking for people who are:
Male or female, aged 21-64, and have health insurance.
Who else is applying?
What state do they live in?
| Texas | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Michael E. DeBakey Veterans Affairs Medical Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
| Phone Call | 100.0% |
Most responsive sites:
- Michael E. DeBakey Veterans Affairs Medical Center: < 24 hours
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Conditions
Cancer Related
Treatments