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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04480827 | Open-Label Study to Evaluate the Safety, Tolerability, and PK of Aramchol in Subjects With Hepatic Impairment | PHASE1 | COMPLETED | 57 | — | — | Feb 13, 2020 | Mar 24, 2022 | Aug 14, 2024 | 3 | United States |
AUC from time 0 to the dosing interval tau measured at steady state. Blood was collected at the following time points: before dosing (0 hour) and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 48, 72, 96, 120, 144, 168, 192, and 240 hours
Maximum plasma concentrations (Cmax,ss) Blood was collected at the following time points: before dosing (0 hour) and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 48, 72, 96, 120, 144, 168, 192, and 240 hours
CL/F measured after single dose in Part 1 Blood was collected at the following time points: before dosing (0 hour) and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 48, 72, 96, 120, 144, 168, 192, and 240 hours
| Arm | Type | Description |
|---|---|---|
| Part 1: Mild Hepatic Impairment (Cohort A) | EXPERIMENTAL | 8 mild hepatic impaired subjects |
| Part 1: Moderate Hepatic Impairment (Cohort B) | EXPERIMENTAL | 8 moderate hepatic impaired subjects |
| Part 1: Severe Hepatic Impairment (Cohort C) | EXPERIMENTAL | 8 severe hepatic impaired subjects |
| Part 1: Healthy Volunteers (Cohort D) | EXPERIMENTAL | 15 matched healthy volunteers |
| Part 2: Mild Hepatic Impairment Cohort | EXPERIMENTAL | 4 mild hepatic impaired subjects |
| Part 2: Moderate Hepatic Impairment Cohort | EXPERIMENTAL | 7 moderate hepatic impaired subjects |
| Part 2: Healthy Volunteers Cohort | EXPERIMENTAL | 7 matched healthy volunteers |
| Name | Type | Description |
|---|---|---|
| Aramchol free acid tablet 600mg, single dose | DRUG | Aramchol free acid tablet 600mg, single dose |
| Aramchol free acid tablet 300mg, bid | DRUG | Aramchol acid tablet 300mg, bid for 12 days |
Inclusion Criteria: 1. The subject is male or female 18 to 79 years of age, inclusive. 2. The subject has a body mass index of 19 to 40 kg/m2, inclusive, at screening. 3. Females of childbearing potential must practice a highly effective method of contraception throughout the study period and for 1...