Food-effect Study of Ecopipam Pharmacokinetics

NCT06669091 | Completed Phase 1 FDA Drug

• 1 other identifier: EBS-101-HV-107
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Standard food-effect study to identify the effect of food on ecopipam pharmacokinetics after administration of a to-be-marketed ecopipam tablet in healthy volunteers.

Conditions

Food-effect

Outcome Measures

Primary Outcomes (10)

• Cmax of ecopipam after administration of an ecopipam tablet in the fed state

  Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 13

• Tmax of ecopipam after administration of an ecopipam tablet in the fed state

  Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 13

• AUC of ecopipam after administration of an ecopipam tablet in the fed state

  Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 13

• AUCinf of ecopipam after administration of an ecopipam tablet in the fed state

  Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 13

• AUClast of ecopipam after administration of an ecopipam tablet in the fed state

  Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 13

• Cmax of ecopipam after administration of an ecopipam tablet in the fasted state

  Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 13

• Tmax of ecopipam after administration of an ecopipam tablet in the fasted state

  Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 13

• AUC of ecopipam after administration of an ecopipam tablet in the fasted state

  Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 13

• AUClast of ecopipam after administration of an ecopipam tablet in the fasted state

  Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 13

• AUCinf of ecopipam after administration of an ecopipam tablet in the fasted state

  Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 13

Secondary Outcomes (44)

• Cmax of EBS-101-40853 after administration of an ecopipam tablet in the fed state

  Up to Day 13

• Tmax of EBS-101-40853 after administration of an ecopipam tablet in the fed state

  Up to Day 13

• AUClast of EBS-101-40853 after administration of an ecopipam tablet in the fed state

  Up to Day 13

• AUCinf of EBS-101-40853 after administration of an ecopipam tablet in the fed state

  Up to Day 13

• Cmax of EBS-101-40853 after administration of an ecopipam tablet in the fasted state

  Up to Day 13

Study Arms (2)

Dosed in fasted state

OTHER

Ecopipam will be taken in the morning in a fasted state

Drug: Ecopipam tablet

Dosed in fed state

OTHER

Ecopipam will be taken in the morning after a standard high-fat breakfast

Drug: Ecopipam tablet

Interventions

Ecopipam tablet DRUG

A single ecopipam 89.6 mg tablet (equivalent to ecopipam HCl 100 mg)

Dosed in fasted state; Dosed in fed state

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
• 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.

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 1 month 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
• Use of tobacco or nicotine products within 1 month prior to Screening
• Significant alcohol consumption or history of abuse
• History of drug abuse within the previous 2 years, or a positive drug screen
• History of cannabinoid use within the previous 3 months
• Positive urine drug screen, urine cotinine test, or alcohol breath test
• History of allergy to study medications
• Recent participation in a clinical research study
• Prior exposure to ecopipam

Sponsors & Collaborators

• Emalex Biosciences Inc.: lead

Study Sites (1)

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

ecopipam

Study Officials

• Frederick Munschauer, MSc, MD, FAAN

  Emalex Biosciences

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: November 5, 2024
• Primary Completion: December 22, 2024
• Study Completion: December 27, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)