Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05835180 | A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function | PHASE1 | COMPLETED | 48 | — | — | May 1, 2023 | Dec 18, 2023 | Dec 26, 2023 | 3 | United States, Hungary |
Total TVB-2640 plasma concentration-time curve during a dosing interval at steady-state
Unbound TVB-2640 plasma concentration-time curve during a dosing interval at steady-state
| Arm | Type | Description |
|---|---|---|
| TVB-2640 50 mg - normal hepatic function | EXPERIMENTAL | Healthy subjects with normal hepatic function receive 50 mg PO daily from Day 1 to Day 4 |
| TVB-2640 50 mg - mild hepatic function | EXPERIMENTAL | Subjects with mild hepatic impairment will receive 50 mg PO daily from Day 1 to Day 4 |
| TVB-2640 50 mg - moderate hepatic function | EXPERIMENTAL | Subjects with moderate hepatic impairment will receive 50 mg PO daily from Day 1 to Day 4 |
| TVB-2640 50 mg - severe hepatic function | EXPERIMENTAL | Subjects with severe hepatic impairment will receive 50 mg PO daily from Day 1 to Day 4 |
| Name | Type | Description |
|---|---|---|
| TVB-2640 - 50 mg | DRUG | TVB-2640 -50 mg administered orally once daily |
Key Inclusion Criteria: Subjects must satisfy all of the following criteria at the Screening visit unless otherwise stated: All Subjects * Males or females, of any race, between 18 and 75 years of age, inclusive. * Body mass index between 18.0 and 42.0/45.0 kg/m2 (inclusive; up to 42.0 kg/m2 for ...