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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001596-39 | EudraCT Number |
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This study will assess the pharmacokinetics of RLX030 during and after administration in subjects with mild to severe hepatic impairment and matched healthy control subjects.
20 to 24 patients and 20 to 24 healthy subjects will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RLX030: Group 1 mild hepatic impairment | Experimental | Patients with mild hepatic impairment will receive a single IV 24 hour infusion of RLX030 |
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| RLX030: Group 2 moderate hepatic impairment | Experimental | Patients with moderate hepatic impairment will receive a single IV 24 hour infusion of RLX030 |
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| RLX030: Group 3 severe hepatic impairment | Experimental | Patients with severe hepatic impairment will receive a single IV 24 hour infusion of RLX030 |
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| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RLX030A | Drug | RLX030 is administered as a continuous 24 hour infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum concentration-time curve from time zero to infinity (AUCinf) | Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030 | Up to Day 15 |
| Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) | Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030 | Up to Day 15 |
| Serum concentration at 24 hour (C24h) after administration | Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030 | Upto Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events, serious adverse events and death | Monitoring of adverse events, serious adverse events and death from screening to end of study | Day 15 |
| Determination of the presence and quantification of anti-RLX030 antibodies |
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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 impairment:
Exclusion criteria:
All subjects
Subjects with hepatic impairment:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Grünstadt | D-67269 | Germany | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25511105 | Derived | Kobalava Z, Villevalde S, Kotovskaya Y, Hinrichsen H, Petersen-Sylla M, Zaehringer A, Pang Y, Rajman I, Canadi J, Dahlke M, Lloyd P, Halabi A. Pharmacokinetics of serelaxin in patients with hepatic impairment: a single-dose, open-label, parallel group study. Br J Clin Pharmacol. 2015 Jun;79(6):937-45. doi: 10.1111/bcp.12572. |
| Label | URL |
|---|---|
| Results for CRLX030A2101 can be found on the Novartis Clinical Trial Results Website | View source |
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Blood will be collected and serum analyzed for the presence of antiRLX030 antibodies. Anti-RLX030 antibodies will be evaluated in serum in a validated four-tiered assay approach |
| Day 1 (prior to administration) and Day 15 end of study |
| Mean residence time [MRT] 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 | screening, days 1, 2, 3, 4 and 15 |
| Terminal elimination half life (T ½) 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 | screening, days 1, 2, 3, 4 and 15 |
| Systemic clearance of RLX030 from serum (CL) | Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030 | screening, days 1, 2, 3, 4 and 15 |
| Volume of distribution at steady state (Vss) | Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030 | screening, days 1, 2, 3, 4 and 15 |
| Moscow |
| 115419 |
| Russia |