Clinical Trials Logo
  1. Home
  2. Drug Interaction
  3. NCT04902105

Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite

Drug Interaction Clinical Trial

Official title:
A Phase 1, Open-Label, Fixed Sequence, Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of Uridine 5'-Diphosphate-glucuronosyltransferases (UGTs) on the Pharmacokinetics of Ecopipam Tablets and Its Active Metabolite (EBS-101-40853) in Healthy Subjects

Clinical Trial Summary

This is a single center, open-label, fixed sequence, drug-drug interaction (DDI) study in healthy subjects.

Clinical Trial Description

Following a 28-day Screening period, eligible subjects will enter the clinical research unit (CRU) and will be enrolled into either Cohort A or B. Subjects in both cohorts will receive a single dose of ecopipam on Day 1. On Day 7, subjects will begin taking a UGT inhibitor according to their assigned cohort. Subjects in Cohort A will receive mefenamic acid 250 mg every 6 hours for 7 days, while subjects in Cohort B will receive divalproex sodium ER 1250 mg once a day for 10 days. A single oral dose of ecopipam will also be administered to Cohort A on Day 7, 1 hour after the first dose of mefenamic acid, and to Cohort B on Day 10, 1 hour after administration of divalproex sodium ER. Subjects in Cohort A will continue taking mefenamic acid through the evening of Day 13 and will remain in the CRU until discharged on Day 14/ET. Subjects in Cohort B will continue taking divalproex sodium ER through Day 16 and will remain in the CRU until discharge on Day 17/ET. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04902105
Study type Interventional
Source Emalex Biosciences Inc.
Contact
Status Completed
Phase Phase 1
Start date May 13, 2021
Completion date July 6, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT04645940 - Fruquintinib Food Effect and Proton Pump Inhibitor Study Phase 1
Completed NCT04540965 - Impact of a Histamine H2 Receptor Antagonist (H2RA) on the Pharmacokinetics (PK) of Telaglenastat in Healthy Subjects Phase 1
Completed NCT04531072 - Effect of Atazanavir-ritonavir on the Pharmacokinetics and Toxicity of Lumefantrine Phase 4
Completed NCT03385525 - Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074 Phase 1
Completed NCT05680792 - Pharmacokinetic Interaction Between Nitazoxanide and Atazanavir/Ritonavir in Healthy Volunteers N/A
Completed NCT05137548 - A Drug-Drug Interaction Study Between ATI-2173 and Tenofovir Disoproxil Fumarate in Healthy Subjects Phase 1
Not yet recruiting NCT05525351 - The Application and Validation of Triple Drug Response Surface Models on Density Spectral Array in Clinical Anesthesia
Terminated NCT01980342 - Pharmacokinetics and Pharmacodynamics of the Etonogestrel Contraceptive Implant When Co-administered With Efavirenz Phase 4
Completed NCT04080596 - DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin Phase 1
Recruiting NCT04593680 - Assessment of Drug-drug Interactions Between Masculinizing Hormone Therapy and Antiretroviral Agents Concomitantly for Pre-exposure Prophylaxis Among Transgender Men N/A
Active, not recruiting NCT04590417 - Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomitantly for Pre-exposure Prophylaxis Among Transgender Women N/A
Completed NCT05633147 - Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam Phase 1
Completed NCT02391688 - Evaluation of the Potential Pharmacokinetic Interactions Between Probe Drugs in the Geneva Phenotyping Cocktail Phase 1
Completed NCT00806299 - Loperamide Grapefruit Juice Interaction PK Trial Phase 1
Completed NCT03336346 - Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana
Completed NCT04818086 - Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder Phase 1/Phase 2
Completed NCT03187015 - A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult Subjects Phase 1
Not yet recruiting NCT04463576 - Drug Interactions in Hospital Information System. The PRoSIT System..
Not yet recruiting NCT03920566 - The Effect of ENZAlutamide on the Anti-Xa Levels of Patients Receiving DOACs
Completed NCT03011996 - To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration Phase 1