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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05751759 | Pharmacokinetics of Mitiperstat in Participants With Hepatic Impairment | PHASE1 | COMPLETED | 31 | — | — | Mar 20, 2023 | Nov 21, 2024 | Dec 5, 2024 | 5 | United States |
The Cmax of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
The AUCinf of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
The AUClast of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
The t½λz of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The tmax of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The CL/F of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The Vz/F of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The Ae(0-24) of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The CLR of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The CLNR of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The fe(0-24) of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 8 participants with mild hepatic impairment (Child-Pugh A) will be given Dose A of mitiperstat. |
| Cohort 2 | EXPERIMENTAL | 8 participants with moderate hepatic impairment (Child-Pugh B) will be given Dose A of mitiperstat. |
| Cohort 3 | EXPERIMENTAL | 6-8 participants with severe hepatic impairment (Child-Pugh C) will be given Dose A of mitiperstat. |
| Cohort 4 | EXPERIMENTAL | 8-12 participants with normal hepatic function will be given Dose A of mitiperstat. |
| Name | Type | Description |
|---|---|---|
| Mitiperstat | DRUG | Participants receive mitiperstat orally. |
Inclusion Criteria: * Participant must be ≥ 18 to ≤ 85 years (inclusive), at the time of signing the informed consent. * Weight ≥ 50kg and BMI ≥ 18 kg/m2 up to \< 42 kg/m2. * Male and/or females. * Contraceptive use by females should be consistent with local regulations regarding the methods of con...