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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-13

Study Completion Date

2021-07-06

Brief Summary

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

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Detailed Description

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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.

Conditions

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Drug Interaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort A

Ecopipam HCL - 2 doses of 200mg

Mefenamic acid 250mg Q6H for 7 days

Group Type OTHER

ecopipam HCL

Intervention Type DRUG

oral tablets

Mefenamic acid

Intervention Type DRUG

oral capsules

Cohort B

Ecopipam HCL - 2 doses of 200mg

Divalproex acid 1250mg QD for 10 days

Group Type OTHER

ecopipam HCL

Intervention Type DRUG

oral tablets

Divalproex Sodium ER

Intervention Type DRUG

oral tablets

Interventions

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ecopipam HCL

oral tablets

Intervention Type DRUG

Mefenamic acid

oral capsules

Intervention Type DRUG

Divalproex Sodium ER

oral tablets

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes