Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RLX030A · 1 trial · 1 indication
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...
RLX030A is an investigational small molecule being studied for hepatic impairment. It is a Phase 1 drug candidate developed by Novartis AG. The drug is intended for use in patients with mild, moderate, and severe hepatic impairment, as well as healthy subjects, to evaluate its pharmacokinetics in these populations.
The molecular target of RLX030A has not been disclosed. The drug is a small molecule in development for hepatic impairment, but its specific mechanism of action and molecular target are not publicly available at this time.
RLX030A is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's pharmacokinetics in subjects with hepatic impairment.
RLX030A is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied to assess its pharmacokinetics in subjects with hepatic impairment compared to healthy subjects.
RLX030A has one completed clinical trial registered under NCT01433458. This Phase 1 study evaluated the pharmacokinetics of RLX030A in subjects with mild, moderate, and severe hepatic impairment compared to healthy subjects. The trial enrolled 55 participants and was conducted in Germany and Russia.
RLX030A is a variant of RLX030, which is also known as serelaxin. RLX030A is being studied for hepatic impairment, while RLX030 is a different formulation or derivative. The two are related but distinct drug candidates in Novartis's pipeline.