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

Launched by SAGIMET BIOSCIENCES INC. · Dec 12, 2022

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• 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.