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

Healthy Volunteer Clinical Trial

Official title:

A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Ecopipam Following a Single Oral Capsule Dose in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04881955
• Other study ID #: EBS-101-HV-103
• Status: Completed
• Phase: Phase 1
• Start date: May 12, 2021
• Est. completion date: September 7, 2021

Study information

• Verified date: December 2021
• Source: Emalex Biosciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male subjects. Potential subjects will be screened to assess their eligibility to enter the study within 29 days prior to dose administration. Subjects will be admitted into the clinical research unit (CRU) on Day -1 and be confined to the CRU until at least Day 8 (Discharge). On Day 1, subjects will receive a single oral dose of 200 mg ecopipam HCl containing approximately 88.5 µCi of [14C]-ecopipam HCl. Subjects will be discharged when the following discharge criteria are met:

• plasma radioactivity levels below the limit of quantitation for 2 consecutive collections;

• ≥ 90% mass balance recovery; and

• ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods in which collections occur. If discharge criteria are not met on Day 8, subjects will remain in the CRU and additional 24-hour collections (blood, urine, and feces) for total radioactivity will continue until these criteria are met, up to a maximum of Day 15.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 7, 2021
• Est. primary completion date: September 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Not suitable for study in the opinion of the Principal Investigator

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• [14C]-Ecopipam
[14C]-Ecopipam

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit Ltd.	Leeds

Sponsors (2)

Lead Sponsor	Collaborator
Emalex Biosciences Inc.	Covance

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of radioactivity excreted in urine (Aeu)	Up to 18 urine samples will be collected at the indicated time points	Up to Day 15
Primary	Cumulative radioactivity excreted in urine (Aeu)	Up to 18 urine samples will be collected at the indicated time points	Up to Day 15
Primary	Amount of radioactivity excreted in feces (Aef)	Up to 16 feces samples will be collected at the indicated time points	Up to Day 15
Primary	Cumulative radioactivity excreted in feces (Aef)	Up to 16 feces samples will be collected at the indicated time points	Up to Day 15
Primary	Percentage of dose excreted in urine (feu)	Up to 18 urine samples will be collected at the indicated time points	Up to Day 15
Primary	Percentage of dose excreted in feces (fef)	Up to 16 feces samples will be collected at the indicated time points	Up to Day 15
Primary	Cumulative dose excreted in urine (feu)	Up to 18 urine samples will be collected at the indicated time points	Up to Day 15
Primary	Cumulative dose excreted in feces (fef)	Up to 16 feces samples will be collected at the indicated time points	Up to Day 15
Primary	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
Primary	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
Primary	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
Primary	Maximum observed concentration (Cmax) radioactivity feces + urine)	Up to 28 blood samples will be collected at the indicated time points	Up to Day 15
Primary	Time of Cmax (Tmax)	Up to 28 blood samples will be collected at the indicated time points	Up to Day 15
Primary	Apparent terminal elimination half-life (t1/2)	Up to 28 blood samples will be collected at the indicated time points	Up to Day 15
Primary	Apparent total clearance (CL/F; ecopipam only)	Up to 28 blood samples will be collected at the indicated time points	Up to Day 15
Primary	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
Primary	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
Primary	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	Percentage of ecopipam and metabolites to total radioactivity in plasma	Up to 28 blood samples will be collected at the indicated time points	Up to Day 15
Secondary	Percentage of ecopipam and metabolites to total radioactivity in urine and faeces	Up to 18 urine and faeces samples will be collected at the indicated time points	Up to Day 15