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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01531309 | Pharmacokinetics of AGO178 in Participants With Liver Impairment | PHASE1 | COMPLETED | 32 | — | — | Feb 8, 2011 | Sep 2, 2011 | May 11, 2021 | 1 | United States |
Blood samples will be collected at various time points on day 1 and day 2
Blood samples will be collected at various time points on day 1 and day 2
| Arm | Type | Description |
|---|---|---|
| Mild Hepatic Impaired Participants | EXPERIMENTAL | Mild hepatic impaired participants will receive a single sublingual dose of AGO178, 1 milligram (mg) on Day 1. |
| Moderate Hepatic Impaired Participants | EXPERIMENTAL | Moderate hepatic impaired participants will receive a single sublingual dose of AGO178, 1 mg on Day 1. |
| Healthy Participants Matched by Aged, Gender and Body Mass Index (BMI) | EXPERIMENTAL | Healthy participants matched by aged, gender and BMI will receive a single sublingual dose of AGO178, 1 mg on Day 1. |
| Name | Type | Description |
|---|---|---|
| AGO178 | DRUG | AGO178 is administered as a sublingual tablet. |
Inclusion Criteria: * Participants with liver disease confirmed within 3 months of screening. * If liver impairment is caused by alcohol use, participants must have abstained from alcohol use within 3 months of study start. * Participants must satisfy criteria for Child- Pugh Class A or B. Exclusi...