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

Conditions

• Chronic Hepatitis B Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Feb 20, 2026

Status verified

Feb 2026

Primary completion

Jun 15, 2026

Completion

Jul 1, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

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

Central Contacts

• Aligos Therapeutics Therapeutics
  (800) 466-6059
  [email protected]

Locations (2)

Find similar trials in Orlando, FL

Related Studies

• A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)
  PHASE2 · Recruiting · Aligos Therapeutics · Chandler, Arizona