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

NCT04902105 | Completed Phase 1 FDA Drug

• 1 other identifier: EBS-101-HV-102
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Interaction

Outcome Measures

Primary Outcomes (12)

• Cmax of ecopipam in the presence of mefenamic acid

  Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 16

• Cmax of ecopipam in the absence of mefenamic acid

  Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 16

• Cmax of ecopipam in the presence of divalproex sodium ER

  Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 16

• Cmax of ecopipam in the absence of divalproex sodium ER

  Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 16

• AUCinf of ecopipam in the presence of mefenamic acid

  Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 16

• AUCinf of ecopipam in the absence of mefenamic acid

  Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 16

• AUCinf of ecopipam in the presence of divalproex sodium ER

  Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 16

• AUCinf of ecopipam in the absence of divalproex sodium ER

  Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 16

• AUC0-143 of ecopipam in the presence of mefenamic acid

  Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 16

• AUC0-143 of ecopipam in the absence of mefenamic acid

  Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 16

• AUC0-143 of ecopipam in the presence of divalproex sodium ER

  Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 16

• AUC0-143 of ecopipam in the absence of divalproex sodium ER

  Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  Up to Day 16

Secondary Outcomes (63)

• Cmax of EBS-101-40853

  Up to Day 16

• AUCinf of EBS-101-40853

  Up to Day 16

• AUC0-143 of EBS-101-40853

  Up to Day 16

• Cmax of mefenamic acid

  Up to Day 16

• Tmax of mefenamic acid

  Up to Day 16

Study Arms (2)

Cohort A

OTHER

Ecopipam HCL - 2 doses of 200mg Mefenamic acid 250mg Q6H for 7 days

Drug: ecopipam HCL; Drug: Mefenamic acid

Cohort B

OTHER

Ecopipam HCL - 2 doses of 200mg Divalproex acid 1250mg QD for 10 days

Drug: ecopipam HCL; Drug: Divalproex Sodium ER

Interventions

ecopipam HCL DRUG

oral tablets

Cohort A; Cohort B

Mefenamic acid DRUG

oral capsules

Cohort A

Divalproex Sodium ER DRUG

oral tablets

Cohort B

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
• 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
• 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

Sponsors & Collaborators

• Emalex Biosciences Inc.: lead
• Syneos Health: collaborator
• Nuventra, Inc.: collaborator

Study Sites (1)

Syneos Health Clinical Research Services, LLC.

Miami, Florida, 33136, United States

Location

MeSH Terms

Interventions

Mefenamic Acid

Intervention Hierarchy (Ancestors)

Fenamates; ortho-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

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: May 20, 2021
• First Posted: May 26, 2021
• Study Start: May 13, 2021
• Primary Completion: July 6, 2021
• Study Completion: July 6, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

US (1)