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This Phase 1 non-randomized, open-label, single-dose hepatic impairment study consists of 2 cohorts, conducted in 16 subjects, 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects without hepatic impairment (Cohort 2), matched for age, body weight and, to the extent possible, for sex. The effect of hepatic impairment on the plasma pharmacokinetics of ALG-001075 will be assessed in subjects who have received single oral doses of pevifoscorvir sodium (ALG-000184).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Hepatic Impairment | Experimental | Subjects with hepatic impairment will receive single oral doses of 100 mg pevifoscorvir sodium. Subjects will be followed up for 14 days after the administration of study drug. |
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| Subjects without Hepatic impairment | Experimental | Subjects without hepatic impairment will receive single oral doses of 100 mg pevifoscorvir sodium. Subjects will be followed up for 14 days after the administration of study drug. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pevifoscorvir Sodium (ALG-000184) | Drug | Pevifoscorvir Sodium (ALG-000184) Single oral doses of 100 mg pevifoscorvir sodium |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve [AUC] | PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma | Up to 4 days |
| Time to maximum plasma concentration [Tmax] | PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma | Update to 4 Days |
| Maximum plasma concentration [Cmax] | PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma | Update to 4 days |
| Minimum plasma concentration [Cmin] | PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma | Up to 4 days |
| C0 (predose) | PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma | Up to 4 days |
| Half-life [t1/2] | PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma | Up to 4 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 15 days |
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Inclusion Criteria:
Inclusion Criteria for Subjects with Normal Hepatic Function:
Inclusion Criteria for Subjects with Impaired Hepatic Function:
Exclusion Criteria for All Subjects:
Exclusion Criteria for Subjects with Normal Hepatic Function:
Exclusion Criteria for Subjects with Impaired Hepatic Function:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jen Rito | Contact | (800) 466-6059 | info@aligos.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Recruiting | Orlando | Florida | 32809 | United States |
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This Phase 1 non-randomized, open-label, single-dose hepatic impairment study consists of 2 cohorts, conducted in 16 subjects, 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects without hepatic impairment (Cohort 2), matched for age, body weight and, to the extent possible, for sex.
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