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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02177786 | Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease | PHASE2 | COMPLETED | 334 | — | — | Jun 1, 2014 | Aug 1, 2016 | Nov 5, 2019 | 105 | United States, Canada |
| NCT02509624 | Study to Evaluate the Pharmacokinetics of Selonsertib in Participants With Normal and Impaired Hepatic Function | PHASE1 | COMPLETED | 52 | — | — | Aug 18, 2015 | Dec 15, 2015 | Jan 27, 2021 | 5 | United States |
The values of eGFR were calculated using the MDRD equation: eGFR = 175 x Serum Creatinine\^-1.154 × age\^-0.203 × 1.212 (if participant is black) × 0.742 (if female).
AUCinf is defined as the concentration of drug extrapolated to infinite time.
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Cmax is defined as the maximum concentration of drug.
| Arm | Type | Description |
|---|---|---|
| Selonsertib 2 mg | EXPERIMENTAL | Participants will receive selonsertib 2 mg for 48 weeks. |
| Selonsertib 6 mg | EXPERIMENTAL | Participants will receive selonsertib 6 mg for 48 weeks. |
| Selonsertib 18 mg | EXPERIMENTAL | Participants will receive selonsertib 18 mg for 48 weeks. |
| Placebo to match selonsertib | PLACEBO_COMPARATOR | Participants will receive placebo to match selonsertib for 48 weeks. |
| Moderate hepatic impairment (Cohort 1) | EXPERIMENTAL | Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of selonsertib on Day 1. |
| Severe hepatic impairment (Cohort 2) | EXPERIMENTAL | Participants with severe hepatic impairment and matched healthy controls will receive a single dose of selonsertib on Day 1. |
| Mild hepatic impairment (Cohort 3) | EXPERIMENTAL | Participants with mild hepatic impairment and matched healthy controls will receive a single dose of selonsertib on Day 1. |
| Name | Type | Description |
|---|---|---|
| Selonsertib | DRUG | Tablets administered orally once daily |
| Placebo to match selonsertib | DRUG | Tablets administered orally once daily |
Key Inclusion Criteria: * Adult male or females with prior diagnosis of Diabetic Kidney Disease * Type 2 diabetes mellitus diagnosis for at least 6 months * eGFR (MDRD) at screening ≥ 15 mL/min/1.73m\^2 to \< 60 mL/min/1.73m\^2 * Urine albumin to creatinine ratio (UACR) as follows: * Stage/Strat...