Drug Interaction Study

NCT06194864 | Completed Phase 1 FDA Drug

• 1 other identifier: EBS-101-HV-106
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, 2-Part, Phase 1, open-label, fixed-sequence, drug-drug interaction study designed to compare the PK of ecopipam when administered alone and in combination with itraconazole (Part 1) or rifampicin (Part 2) in healthy subjects.

Conditions

Drug Interaction

Outcome Measures

Primary Outcomes (16)

• AUC0-inf of ecopipam when administered with itraconazole

  Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 21

• AUC0-inf of ecopipam when administered without itraconazole

  Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 21

• AUC0-inf of ecopipam when administered with rifampicin

  Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 21

• AUC0-inf of ecopipam when administered without rifampicin

  Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 21

• AUC0-t of ecopipam when administered with itraconazole

  Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 21

• AUC0-t of ecopipam when administered without itraconazole

  Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 21

• AUC0-t of ecopipam when administered with rifampicin

  Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 21

• AUC0-t of ecopipam when administered without rifampicin

  Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 21

• Cmax of ecopipam when administered with itraconazole

  Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 21

• Cmax of ecopipam when administered without itraconazole

  Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 21

• Cmax of ecopipam when administered with rifampicin

  Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 21

• Cmax of ecopipam when administered without rifampicin

  Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 21

• T½ el of ecopipam when administered with itraconazole

  Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 21

• T½ el of ecopipam when administered without itraconazole

  Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 21

• T½ el of ecopipam when administered with rifampicin

  Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 21

• T½ el of ecopipam when administered without rifampicin

  Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 21

Secondary Outcomes (63)

• AUC0-inf of EBS-101-40853

  Up to Day 21

• AUC0-inf of ecopipam glucuronide

  Up to Day 21

• AUC0-inf of EBS-101-40853 glucuronide

  Up to Day 21

• AUC0-t of EBS-101-40853

  Up to Day 21

• AUC0-t of ecopipam glucuronide

  Up to Day 21

Study Arms (2)

Part 1

EXPERIMENTAL

ecopipam 89.6 mg on Days 1 and 9 with repeat doses of itraconazole Days 6-16.

Drug: Itraconazole; Drug: Ecopipam

Part 2

EXPERIMENTAL

ecopipam 179.2 mg on Days 1 and 13 with repeat doses of rifampicin days 6-20.

Drug: rifampicin; Drug: Ecopipam

Interventions

Itraconazole DRUG

itraconazole 200 mg QD Days 6 to 16

Part 1

rifampicin DRUG

rifampicin 600 mg QD Days 6 to 20

Part 2

Ecopipam DRUG

89.6 mg on Days 1 and 9 for Part 1 or 179.2 mg on Days 1 and 13 for Part 2

Part 1; Part 2

Eligibility Criteria

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

You may qualify if:

• Male subjects or femail subjects of non-childbearing potential
• ≥18 and ≤55 years of age
• BMI \>18.5 and \<30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
• Subjects must be healthy, as determined by the Investigator, based on medical history, physical examination, ECG, vital signs, 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.
• Willing to take off dentures or mouth piercing at the time of dosing.

You may not qualify if:

• 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 8 weeks 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
• Female subjects who are currently pregnant or lactating
• Positive pregnancy test
• Positive urine drug screen, urine cotinine test, or alcohol breath test
• Use of tobacco or nicotine products within 1 month prior to Screening
• Significant alcohol consumption
• History of drug abuse within the previous year, or a positive drug screen
• History of allergy to study medications
• Part 1 only: Presence of orthodontic braces or orthodontic retention wires

Sponsors & Collaborators

• Emalex Biosciences Inc.: lead
• Syneos Health: collaborator
• Cambridge Cognition Ltd: collaborator

Study Sites (1)

Syneos Health Clinic Inc.

Québec, Quebec, G1P 0A2, Canada

Location

MeSH Terms

Interventions

Itraconazole; Rifampin; ecopipam

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Rick Munschauer, MSc, MD, FAAN

  Emalex Biosciences

  STUDY DIRECTOR

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: December 22, 2023
• First Posted: January 8, 2024
• Study Start: January 18, 2024
• Primary Completion: May 14, 2024
• Study Completion: May 22, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CA (1)