Effects of Ethanol on the Pharmacokinetics of PT-150 (Formerly ORG34517) (PT150 PK Study) (NCT04331288) | Clinical Trial Compass
CompletedPhase 1
Effects of Ethanol on the Pharmacokinetics of PT-150 (Formerly ORG34517) (PT150 PK Study)
United States10 participantsStarted 2021-11-01
Plain-language summary
The purpose of this clinical study is to assess pharmacokinetic interactions between ethanol (EtOH) and PT150 (900 mg qd) in non-treatment-seeking alcohol-experienced volunteers-(to include military service members, veterans and/or civilians).
Who can participate
Age range21 Years – 64 Years
SexALL
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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 form;
✓. Male or female, aged 21-64;
✓. Must score \< 10 on the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar) assessed in the context of a BAL ≤ 0.00% to demonstrate that they do not need medical detoxification;
✓. Must have blood lab test results within the acceptable limits noted in the protocol (Tests may be repeated if initial results are out of range);
✓. Have normal vitals (heart rate 50-100 bpm, systolic blood pressure 90-140 mmHg and diastolic blood pressure 60-90 mmHg) and a baseline 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 judgment 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 the last dose of study drug has been given, 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;
Exclusion criteria
✕. DSM-5 criteria for substance use disorders other than alcohol, nicotine, or marijuana or test positive for prescription or illegal substances other than THC. With regard to marijuana/THC, an individual must agree to abstain from marijuana/THC use three days prior to intake (Day 1/baseline);
What they're measuring
1
Difference in maximum concentration of PT150 (CmaxPT150)
Timeframe: from the PT150 blood draws (days 6-7) to the PT150 with concurrent ethanol blood draws (days 7-9)
2
Difference in time of maximum concentration of PT150 (tmaxPT150)
Timeframe: from the PT150 blood draws (days 6-7) to the PT150 with concurrent ethanol blood draws (days 7-9)
3
Difference in terminal elimination half-life of PT150 (t1/2PT150)
Timeframe: from the PT150 blood draws (days 6-7) to the PT150 with concurrent ethanol blood draws (days 7-9)
4
Difference in area under the concentration-time curve of PT150 (AUCPT150)
Timeframe: from the PT150 blood draws (days 6-7) to the PT150 with concurrent ethanol blood draws (days 7-9)
✕. Be receiving HRT where their dose has not been stable for a minimum of 3 months;
✕. To reduce variability in the magnitude of drug-drug interactions (DDIs), use of concomitant medications (except hormonal birth control) or OTC medications should be excluded for a sufficient time before subject enrollment (at least 14 days or 5 half-lives \[whichever is longer\]) and for the entire duration of the study. These items should be excluded for a longer time period if the DDI mechanism is induction or time-dependent inhibition. Concomitant medication use includes any prescription, over-the-counter medications or dietary/herbal/nutritional supplements;
✕. Be receiving any non-pharmacotherapy treatments or procedures for which there are precautions for taking concomitantly with PT150 and/or those that might interfere with the study;
✕. Have neurological or psychiatric disorders other than AUD or SUD for THC;
✕. History of suicide attempts and/or current suicidal ideation/plan;
✕. Have evidence of untreated or unstable medical illness including: cardiovascular, neuroendocrine, autoimmune, renal, hepatic, or active HIV+, AIDS infection;