Open-label Study of the Absorption, Metabolism, and Excretion of [14C]TVB-2640 Following a Single Oral Dose in Healthy Male Subjects

Study Overview
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Brief Summary
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A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]TVB-2640 healthy male subjects.

Official Title
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A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-TVB-2640 Following a Single Oral Dose in Healthy Male Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: [14C]-TVB-2640


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Males, of any race, between 19 and 55 years of age, inclusive. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at Screening and Check-in as assessed by the Investigator (or designee). History of a minimum of 1 bowel movement per day Key Exclusion Criteria: Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee). History of corneal edema, keratitis, xerophthalmia (dry eye), or other corneal abnormalities. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (cholecystectomy will not be allowed; uncomplicated appendectomy and hernia repair will be allowed). Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines. Use of any sensitive substrates of cytochrome P450 (CYP)2C9 or CYP3A4/5, or inhibitors of CYP3A4 within 30 days prior to IMP administration (Day 1). Donation or loss of ≥ 550 mL blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.

Ages Eligible for Study
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Minimum Age: 19 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm 1<br>Single dose of TVB-2640, 50 mg, oral administration | Drug: [14C]-TVB-2640<br>* 50 mg of TVB-2640 oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [14C]TVB-2640: AUC-inf in plasma |  | Up to 22 days | 
| [14C]TVB-2640: Amount excreted in urine |  | Up to 22 days | 
| [14C]TVB-2640: Amount excreted in feces |  | Up to 22 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Absorption, Metabolism, Excretion, Radiolabeled Dose, Mass Balance [14C]