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

NCT05334108 | Completed Phase 1 FDA Drug

• 1 other identifier: EBS-101-HV-104
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Interaction

Outcome Measures

Primary Outcomes (46)

• Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• Cmax of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• Cmax oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• Cmax of dabigatran in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• Cmax of dabigatran in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• Cmax of rosuvastatin in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• Cmax of rosuvastatin in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUCinf of dabigatran in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUCinf of dabigatran in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUCinf of rosuvastatin in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUCinf of rosuvastatin in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUClast of dabigatran in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUClast of dabigatran in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUClast of rosuvastatin in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUClast of rosuvastatin in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUC0-24 of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUC0-24 of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUC0-24 of dabigatran in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUC0-24 of dabigatran in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUC0-24 of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUC0-24 of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUC0-24 of rosuvastatin in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUC0-24 of rosuvastatin in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUC0-24 of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

• AUC0-24 of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam

  Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 22

Secondary Outcomes (133)

• Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam

  Up to Day 22

• Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam

  Up to Day 22

• Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam

  Up to Day 22

• Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam

  Up to Day 22

• AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam

  Up to Day 22

Study Arms (3)

Cohort 1

OTHER

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

Drug: Ecopipam; Combination Product: Cohort 1 Probe Substrate Cocktail

Cohort 2

OTHER

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

Drug: Ecopipam; Drug: Cohort 2 Probe Substrate

Cohort 3

OTHER

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

Drug: Ecopipam; Combination Product: Cohort 3 Probe Substrate Cocktail

Interventions

Ecopipam DRUG

ecopipam HCl \~2mg/kg/day

Cohort 1; Cohort 2; Cohort 3

Cohort 1 Probe Substrate Cocktail COMBINATION_PRODUCT

dextromethorphan, caffeine, omeprazole, and midazolam

Cohort 1

Cohort 2 Probe Substrate DRUG

bupropion

Cohort 2

Cohort 3 Probe Substrate Cocktail COMBINATION_PRODUCT

dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam

Cohort 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emalex Biosciences Inc.: lead
• ICON Early Phase Services: collaborator
• Nuventra, Inc.: collaborator

Study Sites (1)

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

ecopipam

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 19, 2022
• Study Start: April 26, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 26, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)