An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects

Study Overview
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Brief Summary
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This is an open-label, single dose study in healthy male subjects.

Detailed Description
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A baseline (predose) fecal sample and a baseline (predose) urine sample will be obtained at the clinic prior to dosing on Day 1. On Day 1, subjects will begin the Treatment Phase. Subjects will be released from the clinic after at least 10 days since dosing and as soon as the following conditions are met: greater than 90% of the administered radioactivity has been recovered, and less than 1% of the administered radioactive dose is recovered in two consecutive 24-hour samples each of urine and feces

Official Title
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An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects

Conditions
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Metabolism and Elimination

Intervention / Treatment
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* Drug: E2609


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subjects must meet criteria to be included in this study, including but not limited to the following: Healthy male 18 - 55 years, inclusive, at the time of informed consent Body mass index (BMI) of 18 to 32 kg/m2 at Screening Subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. Sperm donation is not allowed during the study period and for 30 days after study drug discontinuation. Provide written informed consent Willing and able to comply with all aspects of the protocol Exclusion Criteria Subjects who meet any of the following criteria will be excluded from this study: Have participated in a 14C-research study within the 6 months prior to Day -2. The total exposure from this and any previous study must be within the recommended levels considered safe. Exposure to clinically significant radiation within 12 months prior to Day -2. Any laboratory abnormalities considered clinically significant by the investigator, which may require further investigations or treatment Clinically significant illness which required medical treatment within 8 weeks or a clinically significant infection within 4 weeks of dosing Any history of gastrointestinal surgery (e.g., hepatectomy, nephrotomy, digestive organ resection) that may affect PK profiles of study drugs Hypersensitivity to the study drugs or any of their excipients Known to be human immunodeficiency virus (HIV) positive Restrictions will apply on prior and concomitant medications, food and beverages

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E2609<br>Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance | Drug: E2609<br>* Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Elimination of E2609: urine/feces concentration | Total radioactivity will be analyzed in urine and feces predose and up to 28 days postdose. | Predose and every 24 hours postdose up to 28 days | 
| Pharmacokinetics: Plasma concentration of E2609/metabolite | Total radioactivity will be analyzed in whole blood, plasma, and red blood cells. | Predose andup to 648 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Metabolic profile of E2609: plasma/urine/feces concentration | Metabolite profiling in plasma, urine, and feces will be performed by liquid chromatography with radiodetection (radio-high performance liquid chromatography [HPLC]) methods. A scintillation counter and/or AMS will be used to detect radioactivity. If needed, plasma and feces samples will be treated with cysteine and/or other reagents before radio-HPLC analyses. | Predose andup to 648 hours postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolism and Elimination