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

Sponsor

Sagimet Biosciences Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT05657834

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Days)

8.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: [14C]-TVB-2640	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Nov 21, 2022

Actual Primary Completion Date :

Dec 21, 2022

Actual Study Completion Date :

Dec 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm 1 Single dose of TVB-2640, 50 mg, oral administration	Drug: [14C]-TVB-2640 50 mg of TVB-2640 oral administration

Arm

Intervention/Treatment

Experimental: Treatment Arm 1

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

Drug: [14C]-TVB-2640

50 mg of TVB-2640 oral administration

Outcome Measures

Primary Outcome Measures

[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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion Inc.	Lincoln	Nebraska	United States	68502

Sponsors and Collaborators

Sagimet Biosciences Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sagimet Biosciences Inc.

ClinicalTrials.gov Identifier:

NCT05657834

Other Study ID Numbers:

SB2640-CLIN-008

First Posted:

Dec 20, 2022

Last Update Posted:

Dec 28, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sagimet Biosciences Inc.

Study Results

No Results Posted as of Dec 28, 2022