Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 1 non-randomized, open-label, single-dose study of pevifoscorvir sodium (also known as ALG-000184) in participants with severe renal impairment (Part 1), in participants with mild or moderate renal impairment (Optional Part 2) and in participants without renal impairment (Parts 1 and 2), matched for age, body weight and, to the extent possible, for sex.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with renal Impairment | Experimental | Subjects with renal 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. |
|
| Subjects without renal impairment | Experimental | Subjects without renal 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. |
|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve [AUC] | Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302 | Up to 4 days |
| Maximum plasma concentration [Cmax] | Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302 | Up to 4 Days |
| Minimum plasma concentration [Cmin] | Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302 | Up to 4 Days |
| C0 [predose] | Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302 | Up to 4 days |
| Half-life [t1/2] | Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302 | Up to 4 Days |
| Time to maximum plasma concentration [Tmax] | Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302 | Up to 4 Days |
| Apparent Clearance (CL/F) | Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302 | Up to 4 Days |
| Apparent Volume of Distribution (V/F) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent events in subjects with renal impairment and subjects with normal renal function as assessed by DAIDS v2.1 | Up to 15 days |
Not provided
Inclusion Criteria for All Subjects:
Inclusion Criteria for Subjects with Normal Renal Function:
Inclusion Criteria for Subjects with Impaired Renal Function:
Exclusion Criteria for All Subjects:
Exclusion Criteria for Subjects with Normal Renal Function:
1. Hemoglobin <10 g/dL
Exclusion Criteria for Subjects with Impaired Renal Function:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aligos Therapeutics Therapeutics | Contact | (800) 466-6059 | info@aligos.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Recruiting | Orlando | Florida | 32809 | United States |
Not provided
This is a Phase 1 non-randomized, open-label, single-dose study of pevifoscorvir sodium (also known as ALG-000184) in participants with severe renal impairment (Part 1), in participants with mild or moderate renal impairment (Optional Part 2) and in participants without renal impairment (Parts 1 and 2), matched for age, body weight and, to the extent possible, for sex.
Not provided
Not provided
Not provided
Not provided
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
| Up to 4 Days |
| Total Amount of Drug Excreted in Urine (Ae) | Urine PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302 | Up to 4 Days |
| Renal Clearance (CLr) | Urine PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302 | Up to 4 Days |
| Genesis Clinical Trials | Recruiting | Tampa | Florida | 33603 | United States |
|
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided