Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function

Conditions

• Chronic Hepaititis B Infections

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Pevifoscorvir Sodium (ALG-000184) — DRUG
  Pevifoscorvir Sodium (ALG-000184) Single oral doses of 100 mg pevifoscorvir sodium

Study Details

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).

Key Dates

Start date

Jan 30, 2026

Status verified

Feb 2026

Primary completion

Apr 20, 2026

Completion

May 5, 2026

Study Design

Enrollment

16 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Subjects with Hepatic Impairment
  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.
• Experimental: Subjects without Hepatic impairment
  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.

Primary Outcome Measure

Area under the concentration time curve [AUC] [ Time Frame: Up to 4 days ]

Central Contacts

• Jen Rito
  (800) 466-6059
  [email protected]

Locations (1)

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