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

NCT ID: NCT05657834

Last Updated: 2022-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-21
• Study Completion Date: 2022-12-21

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment Arm 1

Single dose of TVB-2640, 50 mg, oral administration

Group Type: EXPERIMENTAL

[14C]-TVB-2640

Intervention Type: DRUG

50 mg of TVB-2640 oral administration

Interventions

[14C]-TVB-2640

50 mg of TVB-2640 oral administration

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sagimet Biosciences Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Celerion Inc.

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

SB2640-CLIN-008

Identifier Type: -

Identifier Source: org_study_id