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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04332432 | A Single-dose, Open-label, Pharmacokinetic Study of Belapectin (GR-MD-02) in Subjects With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment | PHASE1 | COMPLETED | 38 | — | — | Jun 16, 2020 | Mar 9, 2022 | Mar 28, 2022 | 4 | United States |
| Arm | Type | Description |
|---|---|---|
| belapectin | EXPERIMENTAL | Single dose of 4 mg/kg of lean body mass (LBM) belapectin solution for injection administered intravenously (infused over approximately 60 minutes). Group 1: 16 matched healthy subjects with normal hepatic function Group 2: 8 subjects with mild hepatic impairment (Child-Pugh Class A \[4 x subjects with a score of 5 and 4 x subjects with a score of 6\]) Group 3: 8 subjects with moderate hepatic impairment (Child-Pugh Class B \[score of 7 to 9\]) Group 4: 8 subjects with severe hepatic impairment (Child-Pugh Class C \[score of 10 to 14\]). |
| Name | Type | Description |
|---|---|---|
| belapectin | DRUG | intravenous |
Inclusion Criteria: All Subjects 1. Males or females, of any race, between 18 and 75 years of age, inclusive. 2. Body mass index between 18.0 and 45.0 kg/m2, inclusive. 3. Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy t...