Study of Pevifoscorvir Sodium (ALG-000184) for Chronic Hepatitis B
This study is looking at a single dose of Pevifoscorvir Sodium (ALG-000184) to understand how it moves through the body and how safe it is. We are studying 16 people in total: 8 with moderate liver problems (hepatic impairment) and 8 with healthy livers. The goal is to see how liver health affects the drug's levels in the blood over about 4 days. To join, you need to be between 18 and 75 years old, weigh over 110 pounds, and have a BMI between 17.5 and 40. Women who can have children must use effective birth control. The study's status is currently unclear, so it's not known if it's actively recruiting.
- Study design
- This is a Phase 1, open-label study involving 16 participants. It is not randomized, meaning participants are assigned to groups without a random process.
- What's involved
- Participants will receive a single oral dose of Pevifoscorvir Sodium (ALG-000184). Blood samples will be taken to measure drug levels for up to 4 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 4 days after receiving the single dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Area under the concentration time curve [AUC]Up to 4 days
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
- Time to maximum plasma concentration [Tmax]Update to 4 Days
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
- Maximum plasma concentration [Cmax]Update to 4 days
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
- Minimum plasma concentration [Cmin]Up to 4 days
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
- C0 (predose)Up to 4 days
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
- Half-life [t1/2]Up to 4 Days
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma