Hepatic Impairment
Conditions
Brief summary
This a phase 1, open label, single dose, parallel cohort study to determine the pharmacokinetics (PK) of study drug (ESK-001) in healthy volunteer participants, and participants with mild, moderate, and severe hepatic impairment.
Detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Interventions
DRUGESK-001
Single oral dose of ESK-001 in participants from all cohorts
Sponsors
Alumis Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria for All Participants: * Body mass index between 18.0 and 40.0 kg/m2 Key Inclusion Criteria for Participants with Hepatic Impairment: * Diagnosis of chronic (\> 6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history Key
Exclusion criteria
for All Participants: * Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg), or uncontrolled treated/untreated hypotension (systolic blood pressure \< 90 mmHg and/or diastolic blood pressure \< 50 mmHg), or resting pulse rate \< 45 or \> 100 bpm. Measurements may be repeated once in order to determine eligibility Key
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] | 48 hours |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] | 48 hours |
| Maximum observed plasma concentration (Cmax) | 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation | 48 hours |
| Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations | 48 hours |
Countries
United States
Contacts
Primary ContactCentral Contact
Outcome results
None listed