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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05657834
• Other study ID #: SB2640-CLIN-008
• Status: Completed
• Phase: Phase 1
• Start date: November 21, 2022
• Est. completion date: December 21, 2022

Study information

• Verified date: December 2022
• Source: Sagimet Biosciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 21, 2022
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C]-TVB-2640
50 mg of TVB-2640 oral administration

Locations

Country	Name	City	State
United States	Celerion Inc.	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Sagimet Biosciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[14C]TVB-2640: AUC-inf in plasma		Up to 22 days
Primary	[14C]TVB-2640: Amount excreted in urine		Up to 22 days
Primary	[14C]TVB-2640: Amount excreted in feces		Up to 22 days