Healthy Volunteers
Conditions
Keywords
Absorption, Metabolism, Excretion, Radiolabeled Dose, Mass Balance [14C]
Brief summary
A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of \[14C\]TVB-2640 healthy male subjects.
Interventions
DRUG[14C]-TVB-2640
50 mg of TVB-2640 oral administration
Sponsors
Sagimet Biosciences Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed