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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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of \[14C\]TVB-2640 healthy male subjects.

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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Absorption Metabolism Excretion Radiolabeled Dose Mass Balance [14C]

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

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[14C]-TVB-2640

50 mg of TVB-2640 oral administration

Intervention Type DRUG

Eligibility Criteria

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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

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Sagimet Biosciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Celerion Inc.

Lincoln, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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SB2640-CLIN-008

Identifier Type: -

Identifier Source: org_study_id