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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic impairment, matched for age, body weight and, to the extent possible, for gender. The primary purpose of this study is to characterize the effect of hepatic impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily (Q12H) oral (PO) doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Moderate Hepatic Impairment (Child-Pughs Class B) | Experimental | Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses. |
|
| Subjects with Normal Hepatic Function | Experimental | Subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALG-097558 | Drug | Multiple doses of ALG-097558 200 mg (2 x 100 mg tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve [AUC] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma | Pre-dose (-0.75 hours) up to Day 8 |
| Time to maximum plasma concentration [Tmax] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma | Pre-dose (-0.75 hours) up to Day 8 |
| Maximum plasma concentration [Cmax] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma | Pre-dose (-0.75 hours) up to Day 8 |
| Minimum plasma concentration [Cmin] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma | Pre-dose (-0.75 hours) up to Day 8 |
| C0 [predose] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma | Pre-dose (-0.75 hours) up to Day 8 |
| Half-life [t1/2] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma | Pre-dose (-0.75 hours) up to Day 8 |
| 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 20 Days |
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Inclusion Criteria for All Subjects:
4. Female subjects must have a negative serum pregnancy test at screening
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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States | ||
| Orlando Clinical Research Center |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 12, 2026 | |
| Reset | Jul 8, 2026 |
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This study is non-randomized, open-label, parallel group study. Cohort 1 will enroll moderately hepatically impaired subjects and Cohort 2 will enroll subjects without hepatic impairment.
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| Orlando |
| Florida |
| 32809 |
| United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 12, 2026 | Jul 8, 2026 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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