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

NCT ID: NCT05334108

Last Updated: 2022-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-26
• Study Completion Date: 2022-08-26

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cohort 1

ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days

Cohort 1 Probe Substrate Cocktail given on 2 separate days:

• midazolam: 1 µg infused IV
• caffeine: 200 mg oral tablet
• omeprazole: two 20 mg oral tablets
• dextromethorphan: 1.6mL (containing ~10 mg) oral solution

Group Type: OTHER

Ecopipam

Intervention Type: DRUG

ecopipam HCl \~2mg/kg/day

Cohort 1 Probe Substrate Cocktail

Intervention Type: COMBINATION_PRODUCT

dextromethorphan, caffeine, omeprazole, and midazolam

Cohort 2

ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days

Cohort 2 Probe Substrate given on 2 separate days:

• bupropion: 100mg oral tablet

Group Type: OTHER

Ecopipam

Intervention Type: DRUG

ecopipam HCl \~2mg/kg/day

Cohort 2 Probe Substrate

Intervention Type: DRUG

bupropion

Cohort 3

ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days

Cohort 3 Probe Substrate Cocktail given on 3 separate days:

• midazolam: 10 µg/mL given as 1mL oral solution.
• dabigatran: 375 µg/mL and pitavastatin: 10 µg/mL given as 1mL oral solution
• rosuvastatin: 25 µg/mL and atorvastatin: 50 µg/mL given as 2mL oral solution

Group Type: OTHER

Ecopipam

Intervention Type: DRUG

ecopipam HCl \~2mg/kg/day

Cohort 3 Probe Substrate Cocktail

Intervention Type: COMBINATION_PRODUCT

dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam

Interventions

Ecopipam

ecopipam HCl \~2mg/kg/day

Intervention Type: DRUG

Cohort 1 Probe Substrate Cocktail

dextromethorphan, caffeine, omeprazole, and midazolam

Intervention Type: COMBINATION_PRODUCT

Cohort 2 Probe Substrate

bupropion

Intervention Type: DRUG

Cohort 3 Probe Substrate Cocktail

dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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 for males or ≥45 kg for females
• Subjects must be healthy, as determined by the Investigator, based on medical history, physical examination, ECG, and standard panel of blood and laboratory tests at Screening.
• 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
• Positive pregnancy test
• 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
• Undergoing abrupt discontinuation of alcohol or sedatives
• 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

Sponsors

ICON Early Phase Services

UNKNOWN

Sponsor Role: collaborator

Nuventra, Inc.

INDUSTRY

Sponsor Role: collaborator

Emalex Biosciences Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ICON Early Phase Services

San Antonio, Texas, United States

Countries

United States

Other Identifiers

EBS-101-HV-104

Identifier Type: -

Identifier Source: org_study_id