Pharmacokinetic Interactions Between Ethanol and PT150, a Selective Glucocorticoid Receptor Antagonist, in Healthy Volunteers.
Objectives: PT150, a novel competitive glucocorticoid receptor antagonist, is hypothesized to be a potential treatment for alcohol use disorder, with safety studies as an important first step for medication development. We aimed to assess PT150 safety and tolerability, including impact on pharmacoki...
| Published in: | Journal of Addiction Medicine Vol. 20; no. 4; pp. 409 - 416 |
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| Main Authors: | , , , , , , , , , , |
| Format: | clinical trial research tables/charts Journal Article |
| Published: |
Lippincott Williams & Wilkins
Jul2026
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=195928493&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 195928493 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 19320620 3BL0 jtl: Journal of Addiction Medicine issn: 19320620 maglogo: N pubinfo: dt: Jul2026 vid: 20 iid: 4 pid: 433 pub: Lippincott Williams & Wilkins place: Baltimore, Maryland artinfo: ui: 195928493 195928493 195928493 10.1097/ADM.0000000000001557 195928493 ppf: 409 ppct: 7 formats: tig: atl: Pharmacokinetic Interactions Between Ethanol and PT150, a Selective Glucocorticoid Receptor Antagonist, in Healthy Volunteers. aug: au: Vaughan, Adetola Mensah, Cassius K. Pennycuff, Jenny Venneman, Sandy S. Risborough, Victoria Baker, Dewleen G. Nowak, Kayla J. Williams, Rick L. Nolen, Tracy L. Kosten, Thomas R. Verrico, Christopher D. sug: subj: Ethanol Pharmacokinetics Patient Safety Drug Interactions Ethanol Administration and Dosage Receptors, Cell Surface Antagonists and Inhibitors Administration, Oral Alcoholic Beverages Receptors, Cell Surface Pharmacokinetics Alcohol-Related Disorders Drug Therapy Human Dose-Response Relationship, Drug Nonrandomized Trials Academic Medical Centers Texas Texas Adult Middle Age Blood Specimen Collection Clinical Trials Male Female Funding Source Adult: 19-44 years Middle Aged: 45-64 years Male Female ab: Objectives: PT150, a novel competitive glucocorticoid receptor antagonist, is hypothesized to be a potential treatment for alcohol use disorder, with safety studies as an important first step for medication development. We aimed to assess PT150 safety and tolerability, including impact on pharmacokinetics when administered concomitantly with ethanol in healthy participants. Methods: This nonrandomized, single-site, drug-drug interaction study of PT150, coadministered with oral ethanol (alcohol beverage), was conducted at the Michael E. DeBakey Veterans Affairs Medical Center in Houston, TX. Participants, each of whom received the same exposure sequence and served as their own control, were healthy, alcohol-experienced volunteers aged 21–64 years. Blood samples were obtained before and after 1.03 mL/kg ethanol exposure, before and after the fifth dose of PT150 (900 mg/d), and again before and after a sixth dose of PT150 (900 mg/d) administered with 1.03 mL/kg of ethanol. The primary pharmacokinetic outcomes included differences in peak plasma concentrations (C max), time to reach peak plasma concentrations (t max), terminal elimination half-life (t 1/2), and area under the concentration-time curve (AUC) of PT150 alone and in combination with ethanol. Results: There was no statistically significant evidence that coexposure to ethanol impacted PT150 pharmacokinetics, and no statistically significant evidence that coexposure to PT150 impacted ethanol pharmacokinetics. There were no clinically significant abnormal electrocardiograms or serious adverse events. Conclusions: These data suggest that coadministration of PT150 and alcohol does not produce significant pharmacokinetic interactions, supporting the feasibility of evaluating PT150 in future clinical trials for alcohol use disorder. pubtype: Academic Journal doctype: clinical trial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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