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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01433458 | Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects | PHASE1 | COMPLETED | 55 | — | — | Jul 1, 2011 | Dec 1, 2011 | Dec 21, 2020 | 2 | Germany, Russia |
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
| Arm | Type | Description |
|---|---|---|
| RLX030: Group 1 mild hepatic impairment | EXPERIMENTAL | Patients with mild hepatic impairment will receive a single IV 24 hour infusion of RLX030 |
| RLX030: Group 2 moderate hepatic impairment | EXPERIMENTAL | Patients with moderate hepatic impairment will receive a single IV 24 hour infusion of RLX030 |
| RLX030: Group 3 severe hepatic impairment | EXPERIMENTAL | Patients with severe hepatic impairment will receive a single IV 24 hour infusion of RLX030 |
| RLX030: Group 4 - healthy volunteers | ACTIVE_COMPARATOR | Participants will receive a single IV 24 hour infusion of RLX030. This group will consist of 3 sub-groups to match patients of groups 1, 2and 3. |
| Name | Type | Description |
|---|---|---|
| RLX030A | DRUG | RLX030 is administered as a continuous 24 hour infusion |
Inclusion criteria: * All subjects: • Female subjects must be of non-child bearing potential OR use an effective method of contraception and sexually active males must use a condom during intercourse while taking the drug and for 5 half-lives after stopping treatment * Subjects with hepatic impa...