Healthy VolunteersPhase 1NCT05657834
Open-label Study of the Absorption, Metabolism, and Excretion of [14C]TVB-2640 Following a Single Oral Dose in Healthy Male Subjects
A Phase 1 study testing [14C]-TVB-2640 in people with Healthy Volunteers, run by Sagimet Biosciences Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]-TVB-2640
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2022to 21 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- [14C]-TVB-2640
- Keywords
- Absorption, Metabolism, Excretion, Radiolabeled Dose, Mass Balance [14C]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-TVB-2640Drug
50 mg of TVB-2640 oral administration
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Experimental | Single dose of TVB-2640, 50 mg, oral administration Receives: Drug: [14C]-TVB-2640 |
What is being measured
The primary outcome is the main question the study is designed to answer.
[14C]TVB-2640: AUC-inf in plasma
Measured: Up to 22 days
[14C]TVB-2640: Amount excreted in urine
Measured: Up to 22 days
[14C]TVB-2640: Amount excreted in feces
Measured: Up to 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start21 Nov 2022
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sagimet Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657834
- Sponsor's protocol ID
- SB2640-CLIN-008
- Status last verified
- Dec 2022
- First submitted
- 12 Dec 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05657834
- Acronym / sponsor ID
- SB2640-CLIN-008
- Conditions
- Healthy Volunteers
- Keywords
- Absorption, Metabolism, Excretion, Radiolabeled Dose, Mass Balance [14C]
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sagimet Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]TVB-2640 healthy male subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Experimental | Drug: [14C]-TVB-2640Single dose of TVB-2640, 50 mg, oral administration |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-TVB-264050 mg of TVB-2640 oral administration | Drug | Treatment Arm 1 |
Primary outcome
[14C]TVB-2640: AUC-inf in plasma
Time frame: Up to 22 days
[14C]TVB-2640: Amount excreted in urine
Time frame: Up to 22 days
[14C]TVB-2640: Amount excreted in feces
Time frame: Up to 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-TVB-2640 in people with Healthy Volunteers, run by Sagimet Biosciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[14C]TVB-2640: AUC-inf in plasma (time frame: Up to 22 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.