Study of the Absorption, Metabolism, and Excretion of [14C]-Ecopipam in Healthy Male Subjects

NCT04881955 | Completed Phase 1 FDA Drug

• 1 other identifier: EBS-101-HV-103
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1, single-center (United Kingdom), open-label, nonrandomized, single-dose study in healthy adult male subjects to assess the absorption, metabolism, and excretion of \[14C\]-Ecopipam in Healthy Male Subjects.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (18)

• Amount of radioactivity excreted in urine (Aeu)

  Up to 18 urine samples will be collected at the indicated time points

  Up to Day 15

• Cumulative radioactivity excreted in urine (Aeu)

  Up to 18 urine samples will be collected at the indicated time points

  Up to Day 15

• Amount of radioactivity excreted in feces (Aef)

  Up to 16 feces samples will be collected at the indicated time points

  Up to Day 15

• Cumulative radioactivity excreted in feces (Aef)

  Up to 16 feces samples will be collected at the indicated time points

  Up to Day 15

• Percentage of dose excreted in urine (feu)

  Up to 18 urine samples will be collected at the indicated time points

  Up to Day 15

• Percentage of dose excreted in feces (fef)

  Up to 16 feces samples will be collected at the indicated time points

  Up to Day 15

• Cumulative dose excreted in urine (feu)

  Up to 18 urine samples will be collected at the indicated time points

  Up to Day 15

• Cumulative dose excreted in feces (fef)

  Up to 16 feces samples will be collected at the indicated time points

  Up to Day 15

• Percentage of total radioactivity in total excreta (feces + urine)

  Up to 18 urine and feces samples will be collected at the indicated time points

  Up to Day 15

• Area under the plasma concentration versus time curve (AUC) from time zero extrapolated to infinity (AUC0-inf)

  Up to 28 blood samples will be collected at the indicated time points

  Up to Day 15

• AUC from time zero to the last quantifiable concentration (AUC0 last)

  Up to 28 blood samples will be collected at the indicated time points

  Up to Day 15

• Maximum observed concentration (Cmax) radioactivity feces + urine)

  Up to 28 blood samples will be collected at the indicated time points

  Up to Day 15

• Time of Cmax (Tmax)

  Up to 28 blood samples will be collected at the indicated time points

  Up to Day 15

• Apparent terminal elimination half-life (t1/2)

  Up to 28 blood samples will be collected at the indicated time points

  Up to Day 15

• Apparent total clearance (CL/F; ecopipam only)

  Up to 28 blood samples will be collected at the indicated time points

  Up to Day 15

• Apparent volume of distribution (Vz/F; ecopipam only)

  Up to 28 blood samples will be collected at the indicated time points

  Up to Day 15

• AUC0-inf of plasma ecopipam concentration relative to AUC0-inf of plasma total radioactivity (AUC0-inf Plasma ecopipam/Total Radioactivity Ratio)

  Up to 28 blood samples will be collected at the indicated time points

  Up to Day 15

• AUC0-inf of whole blood total radioactivity to AUC0-inf of plasma total radioactivity (AUC0 inf Blood/Plasma Ratio)

  Up to 28 blood samples will be collected at the indicated time points

  Up to Day 15

Secondary Outcomes (2)

• Percentage of ecopipam and metabolites to total radioactivity in plasma

  Up to Day 15

• Percentage of ecopipam and metabolites to total radioactivity in urine and faeces

  Up to Day 15

Study Arms (1)

[14C]-Ecopipam

EXPERIMENTAL

Single oral capsule dose of 200 mg ecopipam HCl containing approximately 88.5 µCi of \[14C\]-ecopipam HCl

Drug: [14C]-Ecopipam

Interventions

[14C]-Ecopipam DRUG

\[14C\]-Ecopipam

[14C]-Ecopipam

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males of any race between 35 and 55 years of age
• Body mass index between 18.0 and 30.0 kg/m2
• In good health
• Males will agree to use contraception
• Able to comprehend and sign an informed consent form
• History of a minimum of 1 bowel movement per day

You may not qualify if:

• History of significant medical illness
• History of clinically significant drug allergy
• History of a seizure disorder, not including infantile seizures
• History of stomach or intestinal surgery that would potentially alter absorption and/or excretion of orally administered drugs
• Clinically significant medical treatment within 8 weeks or infection treatment within 4 weeks of dosing
• Clinically significant ECG abnormality
• History of alcoholism or drug/chemical abuse within the previous 2 years or positive screening test
• Significant alcohol consumption
• Positive hepatitis panel and/or positive human immunodeficiency virus test
• Use of prohibited prescription, over-the-counter medications or natural health products
• Use of tobacco or nicotine-containing products within 3 months prior to Check-in or positive screening test
• Receipt of blood products within 2 months prior to Check in
• Recent donation of blood, plasma, or platelets prior to Screening
• Exposure to significant diagnostic, therapeutic or employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in
• Evidence or history of active suicidal thoughts in the previous 5 years or have any lifetime history of a suicide attempt

Sponsors & Collaborators

• Emalex Biosciences Inc.: lead
• Covance: collaborator

Study Sites (1)

Covance Clinical Research Unit Ltd.

Leeds, LS2 9LH, United Kingdom

Location

Study Design

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

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 11, 2021
• Study Start: May 12, 2021
• Primary Completion: September 7, 2021
• Study Completion: September 7, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)