CompletedPhase 1

Clinical Trial to Evaluate the Safety of PT150 (Formerly ORG34517) When it is Taken Concurrently With Alcohol

United States10 participantsStarted 2018-09-01

Plain-language summary

The purpose of the clinical study is to compare pharmacodynamic and safety endpoints following an alcohol challenge prior to and concurrent with PT150 (study drug) treatment.

Who can participate

Age range21 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: - Provide signed and dated informed consent; * male and female, ages 21 to 64; * must score \<10 on the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar) assessed in the context of a blood alcohol level (BAL) ≤ 0.02% to demonstrate that they do not need medical detoxification; must have blood laboratory test results within acceptable limits (normal range as noted per protocol); * have normal vitals (heart rate 60-100 beats per minute (bpm), systolic blood pressure 90-140 millimeter of mercury (mmHg) and diastolic blood pressure 60-90 mmHg); a baseline electrocardiogram (ECG) that demonstrates clinically normal sinus rhythm, clinically normal conduction, normal QTc, and no clinically significant arrhythmias; * have a self-reported medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgement of the admitting physician; * must be willing to comply with all study procedures and be available for the duration of the study; * women must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or using non-hormonal, medically acceptable contraception during the study and for at least 2 weeks after study completion, with or without additional hormonal contraception Women can be receiving hormone replacement treatment (HRT) as long as the HRT dose has been stable for a period of at least 3 months; * women must provide negat…

What they're measuring

Change in Breath-alcohol levels (BALs) - Cmax

Timeframe: from post-alcohol challenge pre-treatment (day 1)to post alcohol with concurrent intreatment (day 5)

Change in Breath-alcohol levels (BALs) - Tmax

Timeframe: from post-alcohol challenge pre-treatment (day 1)to post alcohol with concurrent treatment (day 5)

Change in Breath-alcohol levels (BALs) - AUC

Timeframe: from post-alcohol challenge pre-treatment (day 1) to post alcohol with concurrent treatment (day 5)

Change in blood pressure

Timeframe: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)

Change in Heart Rate (Pulse)

Timeframe: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)

Change in ECG abnormalities

Timeframe: from pre-treatment (baseline) to post-treatment (day 6)

Change in Positive Affect score from the Positive and Negative Affect Schedule (PANAS)

Timeframe: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)

Trial details

NCT IDNCT03548714

SponsorPop Test Oncology LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-07-15

View on ClinicalTrials.gov More Alcohol Dependence trials

Who can participate

Age range21 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Breath-alcohol levels (BALs) - Cmax

Timeframe: from post-alcohol challenge pre-treatment (day 1)to post alcohol with concurrent intreatment (day 5)

Change in Breath-alcohol levels (BALs) - Tmax

Timeframe: from post-alcohol challenge pre-treatment (day 1)to post alcohol with concurrent treatment (day 5)

Change in Breath-alcohol levels (BALs) - AUC

Timeframe: from post-alcohol challenge pre-treatment (day 1) to post alcohol with concurrent treatment (day 5)

Change in blood pressure

Timeframe: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)

Change in Heart Rate (Pulse)

Timeframe: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)

Change in ECG abnormalities

Timeframe: from pre-treatment (baseline) to post-treatment (day 6)

Change in Positive Affect score from the Positive and Negative Affect Schedule (PANAS)

Timeframe: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)