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

Emalex Biosciences

Status and phase: Completed; Phase 1

Conditions: Drug Interaction

Treatments: Drug: Mefenamic acid; Drug: ecopipam HCL; Drug: Divalproex Sodium ER

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04902105

EBS-101-HV-102

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male subjects or female subjects of non-childbearing potential
• ≥18 and ≤55 years of age at the time of consent
• BMI >18.5 and <30 kg/m2 and a weight of ≥50 kg
• Sexually active males must use a double barrier method of contraception during the study and for at least 90 days after the last dose of study drug
• Male subjects must be willing not to donate sperm until 90 days following the last study drug administration

Exclusion criteria

• Personal or family History of significant medical illness
• Clinically significant abnormalities on screening tests/exams
• History of or significant risk of committing suicide
• Donation of plasma within 7 days prior to dosing
• Donation or significant loss of blood within 30 days prior to the first dosing
• Major surgery within 3 months or minor surgery within 1 month prior to admission
• Use of prohibited prescription, over-the-counter medications or natural health products
• Alcohol-based products 24 hours prior to admission
• Female subjects who are currently pregnant or lactating
• Use of tobacco or nicotine products within 3 months prior to Screening
• Significant alcohol consumption
• History of drug abuse within the previous 2 years, or a positive drug screen
• History of allergy to study medications
• Not suitable for study in the opinion of the Principal Investigator

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Cohort A

Other group

Description:

Ecopipam HCL - 2 doses of 200mg Mefenamic acid 250mg Q6H for 7 days

Treatment:

Drug: ecopipam HCL

Drug: Mefenamic acid

Cohort B

Other group

Description:

Ecopipam HCL - 2 doses of 200mg Divalproex acid 1250mg QD for 10 days

Treatment:

Drug: Divalproex Sodium ER

Drug: ecopipam HCL