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A Phase 1, Open-label, Pharmacokinetic Study of TVB-2640 in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Function.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505180-36-00
Acronym
SB2640-CLIN-009
Enrollment
16
Registered
2023-08-24
Start date
2023-09-21
Completion date
2023-12-18
Last updated
2023-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired Hepatic Function The study will enroll as following: · Group 1 (N up to 24) – Normal hepatic function (healthy subjects) · Group 2 (N 6 to 8) – Mild hepatic impairment (Child-Pugh A - a score of 5 to 6) · Group 3 (N 6 to 8) – Moderate hepatic impairment (Child-Pugh B a score of 7 to 9) · Group 4 (N 6 to 8) – Severe hepatic impairment (Child-Pugh C a score of 10 to 15) Healthy volunteers with normal hepatic function.

Interventions

None listed

Sponsors

Sagimet Biosciences Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Countries

Hungary

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026