NCT06194864

Drug Interaction Study

A Phase 1, Sequential Drug Interaction Study to Evaluate the Effect of CYP3A4 and P-glycoprotein Inhibition by Itraconazole or Induction by Rifampicin on the Pharmacokinetics of Ecopipam and Its Metabolites in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Emalex Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single center, 2-Part, Phase 1, open-label, fixed-sequence, drug-drug interaction study designed to compare the PK of ecopipam when administered alone and in combination with itraconazole (Part 1) or rifampicin (Part 2) in healthy subjects.

Conditions

• Drug Interaction

Interventions

Type	Name	Description
DRUG	Itraconazole	itraconazole 200 mg QD Days 6 to 16
DRUG	rifampicin	rifampicin 600 mg QD Days 6 to 20
DRUG	Ecopipam	89.6 mg on Days 1 and 9 for Part 1 or 179.2 mg on Days 1 and 13 for Part 2

Timeline

• Start date: 2024-01-18
• Primary completion: 2024-05-14
• Completion: 2024-05-22
• First posted: 2024-01-08
• Last updated: 2024-09-19

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study