drugset / Trial / NCT03548714
Clinical Trial to Evaluate the Safety of PT150 (Formerly ORG34517) When it is Taken Concurrently With Alcohol
Phase 1
Completed
10 enrolled
Pop Test Oncology LLC
Baylor College of Medicine · collabCongressionally Directed Medical Research Programs · collabMichael E. DeBakey VA Medical Center · collabPharmacotherapies for Alcohol and Substance Use Disorders Alliance · collabUniversity of California, San Diego · collab
RandomizedParallel-groupQuadruple-blindOther
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.
Timeline
- Start
- 2018-09-01
- Primary completion
- 2019-07-15
- Completion
- 2019-07-15
Publications
- Background Reynolds AR, Saunders MA, Brewton HW, Winchester SR, Elgumati IS, Prendergast MA. Acute oral administration of the novel, competitive and selective glucocorticoid receptor antagonist ORG 34517 reduces the severity of ethanol withdrawal and related hypothalamic-pituitary-adrenal axis activation. Drug Alcohol Depend. 2015 Sep 1;154:100-4. doi: 10.1016/j.drugalcdep.2015.06.018. Epub 2015 Jun 22.
- Background Vendruscolo LF, Estey D, Goodell V, Macshane LG, Logrip ML, Schlosburg JE, McGinn MA, Zamora-Martinez ER, Belanoff JK, Hunt HJ, Sanna PP, George O, Koob GF, Edwards S, Mason BJ. Glucocorticoid receptor antagonism decreases alcohol seeking in alcohol-dependent individuals. J Clin Invest. 2015 Aug 3;125(8):3193-7. doi: 10.1172/JCI79828. Epub 2015 Jun 29.
- Morice C, Baker DG, Patel MM, Nolen TL, Nowak K, Hirsch S, Kosten TR, Verrico CD. A randomized trial of safety and pharmacodynamic interactions between a selective glucocorticoid receptor antagonist, PT150, and ethanol in healthy volunteers. Sci Rep. 2021 May 10;11(1):9876. doi: 10.1038/s41598-021-88609-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ORG 34517 | Small molecule | 900 mg | Oral |