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Healthy VolunteerPhase 1NCT04881955

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

A Phase 1 study testing [14C]-Ecopipam in people with Healthy Volunteer, run by Emalex Biosciences Inc. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 35 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
[14C]-Ecopipam
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited Kingdom
Study dates
12 May 2021to 7 Sep 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Covance Clinical Research Unit Ltd.

    Leeds, LS2 9LH

Other trials in United Kingdom

About this study

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

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.

Read the detailed 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.
Being tested
[14C]-Ecopipam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]-EcopipamDrug

    [14C]-Ecopipam

Study groups in NCT04881955
Study groupRoleWhat they receive
[14C]-EcopipamExperimentalSingle oral capsule dose of 200 mg ecopipam HCl containing approximately 88.5 µCi of [14C]-ecopipam HCl
Receives: Drug: [14C]-Ecopipam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of radioactivity excreted in urine (Aeu)

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

    Measured: Up to Day 15

  2. Cumulative radioactivity excreted in urine (Aeu)

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

    Measured: Up to Day 15

  3. Amount of radioactivity excreted in feces (Aef)

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

    Measured: Up to Day 15

  4. Cumulative radioactivity excreted in feces (Aef)

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

    Measured: Up to Day 15

  5. Percentage of dose excreted in urine (feu)

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

    Measured: Up to Day 15

  6. Percentage of dose excreted in feces (fef)

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

    Measured: Up to Day 15

  7. Cumulative dose excreted in urine (feu)

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

    Measured: Up to Day 15

  8. Cumulative dose excreted in feces (fef)

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

    Measured: Up to Day 15

  9. Percentage of total radioactivity in total excreta (feces + urine)

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

    Measured: Up to Day 15

  10. 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

    Measured: Up to Day 15

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

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

    Measured: Up to Day 15

  12. Maximum observed concentration (Cmax) radioactivity feces + urine)

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

    Measured: Up to Day 15

  13. Time of Cmax (Tmax)

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

    Measured: Up to Day 15

  14. Apparent terminal elimination half-life (t1/2)

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

    Measured: Up to Day 15

  15. Apparent total clearance (CL/F; ecopipam only)

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

    Measured: Up to Day 15

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

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

    Measured: Up to Day 15

  17. 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

    Measured: Up to Day 15

  18. 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

    Measured: Up to Day 15

Secondary outcomes (2)

  1. Percentage of ecopipam and metabolites to total radioactivity in plasma

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

    Measured: Up to Day 15

  2. 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

    Measured: Up to Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2021
  2. Study start12 May 2021
  3. Primary completion7 Sep 2021
  4. Study completion7 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04881955
Sponsor's protocol ID
EBS-101-HV-103
Status last verified
Dec 2021
First submitted
29 Apr 2021
Last updated
3 Dec 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-Ecopipam in people with Healthy Volunteer, run by Emalex Biosciences Inc. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of radioactivity excreted in urine (Aeu) (time frame: Up to Day 15). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04881955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.

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