NCT05334108

Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport

A Phase 1, Open-Label, Fixed Sequence, Drug-Drug Interaction Study to Evaluate the Effects of Repeat Titrated Doses of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Emalex Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects.

Detailed description

Following a Screening period, eligible subjects will be enrolled sequentially to one of three cohorts to receive a single dose of probe substrate(s), followed by repeated titrated doses of ecopipam twice daily (BID) (with subjects in Cohort 3 also receiving a single dose of ecopipam and probe substrates on Day 4 prior to titration). After steady-state ecopipam dosing is reached, ecopipam will be co-administered with a single dose of probe substrate(s) (with continuation of ecopipam BID (every 12 h) dosing during the blood sampling period for the respective probe substrates), followed by an ecopipam tapering period and clinic discharge assessments.

Conditions

• Drug Interaction

Interventions

Type	Name	Description
DRUG	Ecopipam	ecopipam HCl \~2mg/kg/day
COMBINATION_PRODUCT	Cohort 1 Probe Substrate Cocktail	dextromethorphan, caffeine, omeprazole, and midazolam
DRUG	Cohort 2 Probe Substrate	bupropion
COMBINATION_PRODUCT	Cohort 3 Probe Substrate Cocktail	dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam

Timeline

• Start date: 2022-04-26
• Primary completion: 2022-08-01
• Completion: 2022-08-26
• First posted: 2022-04-19
• Last updated: 2022-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study