Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Icenticaftor · 1 trial · 1 indication
Icenticaftor plasma concentrations will be determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Cmax of icenticaftor will be determined with Phoenix WinNonlin (Version 6.4 or higher).
AUClast of icenticaftor will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher). The linear trapezoidal rule will be used for AUClast calculation.
AUCinf of icenticaftor will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher). The linear trapezoidal rule will be used for AUCinf calculation.
Icenticaftor plasma concentrations will be determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Tmax of icenticaftor will be determined with Phoenix WinNonlin (Version 6.4 or higher).
CL/F of icenticaftor will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher).
Vz/F of icenticaftor will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher).
T1/2 of icenticaftor will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher). Regression analysis of the terminal plasma elimination phase will be used for T1/2 calculation.
| Arm | Type | Description |
|---|---|---|
| Group 1 - Healthy subjects with normal hepatic function | EXPERIMENTAL | Healthy subjects with normal hepatic function - Control |
| Group 2 - Mild Hepatic Impairment | EXPERIMENTAL | Mild hepatic impairment: Child-Pugh A (Score 5-6) |
| Group 3 - Moderate Hepatic Impairment | EXPERIMENTAL | Moderate hepatic impairment: Child-Pugh B (Score 7-9) |
| Group 4 - Severe Hepatic Impairment | EXPERIMENTAL | Severe hepatic impairment: Child-Pugh C (Score 10-15) |
| Name | Type | Description |
|---|---|---|
| Icenticaftor | DRUG | Single oral dose of 300 mg of icenticaftor (QBW251) |
All Participants: Inclusion Criteria: * Male and non-child bearing potential female participants, 18 to 75 years of age (inclusive) at Screening. * Participants must weigh at least 50.0 kg and must have a body mass index (BMI) within the range of 18.0 to 38.0 kg/m2, inclusive, at Screening. * Must...
Icenticaftor is an investigational small molecule being studied for use in hepatic failure. It is currently in Phase 1 clinical development, and the completed trial evaluated its pharmacokinetics in participants with hepatic impairment. The drug is not yet approved and remains under investigation.
Icenticaftor is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company conducted a Phase 1 pharmacokinetic study of the drug in participants with hepatic impairment.
Icenticaftor is in Phase 1 clinical development. One Phase 1 trial has been completed, which studied the drug's pharmacokinetics in participants with hepatic impairment. The drug is investigational and has not been approved for any use.
Icenticaftor has one completed clinical trial, identified as NCT04587622, titled 'Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment.' This Phase 1 study enrolled 40 participants in the United States and included healthy volunteers, with a minimum age of 18 years.
Icenticaftor is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT04587622, was a pharmacokinetic study in participants with hepatic impairment, but the drug has not received regulatory approval for any indication.