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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01817985 | A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment | PHASE1 | COMPLETED | 33 | — | — | Mar 1, 2013 | Aug 1, 2013 | Aug 29, 2013 | 6 | United States, Puerto Rico |
The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | (N = 20 Moderately Impaired / Normal Hepatic Function) 100 mg GS-5816. |
| Cohort 2 | EXPERIMENTAL | (N = 20 Severely Impaired / Normal Hepatic Function) up to 100 mg GS-5816. |
| Name | Type | Description |
|---|---|---|
| GS-5816 | DRUG | - |
Inclusion Criteria: * Diagnosis of chronic (\> 6 months), hepatic impairment. * In the opinion of the Investigator, be in good health. Exclusion Criteria: * Severe hepatic encephalopathy. * Prior placement of a portosystemic shunt. * Hepatorenal or hepatopulmonary syndrome. * Suspicion of hepatoc...