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

NCT05657834 | Completed Phase 1 FDA Drug

• 1 other identifier: SB2640-CLIN-008
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

Absorption; Metabolism; Excretion; Radiolabeled Dose; Mass Balance [14C]

Outcome Measures

Primary Outcomes (3)

• [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

Study Arms (1)

Treatment Arm 1

EXPERIMENTAL

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

Drug: [14C]-TVB-2640

Interventions

[14C]-TVB-2640 DRUG

50 mg of TVB-2640 oral administration

Treatment Arm 1

Eligibility Criteria

• Age: 19 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sagimet Biosciences Inc.: lead

Study Sites (1)

Celerion Inc.

Lincoln, Nebraska, 68502, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 20, 2022
• Study Start: November 21, 2022
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)