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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04587622 | Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment | PHASE1 | COMPLETED | 40 | — | — | Oct 30, 2020 | Sep 15, 2022 | Jun 20, 2024 | 2 | United States |
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...