Overview
Sponsor-declared trial summary
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.
Key facts
- Sponsor
- Sagimet Biosciences Inc.
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 21 Sep 2023 → 19 Dec 2023
- Decision date (initial)
- 2023-08-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
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.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.1 | LLT | 10052254 | Hepatic impairment | 10019805 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sagimet Biosciences Inc.
- Sponsor organisation
- Sagimet Biosciences Inc.
- Address
- 155 Bovet Road Suite 303
- City
- San Mateo
- Postcode
- 94402-3135
- Country
- United States
Scientific contact point
- Organisation
- Sagimet Biosciences Inc.
- Contact name
- Eduardo Bruno Martins
Public contact point
- Organisation
- Sagimet Biosciences Inc.
- Contact name
- Eduardo Bruno Martins
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 16 | 1 |
| Rest of world
United States
|
— | 32 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Hungary | 2023-09-21 | 2023-12-18 | 2023-09-21 | 2023-12-18 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-05 | Hungary | Acceptable 2023-08-21
|
2023-08-24 |