Pevifoscorvir Sodium for Chronic Hepatitis B and Kidney Function
This study is testing a single dose of pevifoscorvir sodium (ALG-000184) to see how it moves through the body (pharmacokinetics) and if it's safe and well-tolerated in people with chronic hepatitis B infection. We are looking for participants aged 18 to 75, with or without kidney problems. The main goal is to measure how much pevifoscorvir sodium is in the blood over about four days. This will help us understand how kidney function might affect the drug. This is an open-label study, meaning you and the study team will know what treatment you are receiving. The study aims to enroll 30 participants.
- Study design
- This is a Phase 1, open-label study, meaning everyone knows what treatment is given. It will involve about 30 participants.
- What's involved
- You would receive a single oral dose of pevifoscorvir sodium. Blood samples would be taken to measure drug levels for up to 4 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Drug levels will be measured for up to 4 days after treatment.
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 Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
At a glance
Conditions
Where it's being run
2 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
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
- Maximum plasma concentration [Cmax]Up to 4 Days
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
- Minimum plasma concentration [Cmin]Up to 4 Days
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
- C0 [predose]Up to 4 days
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
- Half-life [t1/2]Up to 4 Days
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
- Time to maximum plasma concentration [Tmax]Up to 4 Days
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
- Apparent Clearance (CL/F)Up to 4 Days
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
- Apparent Volume of Distribution (V/F)Up to 4 Days
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
- Total Amount of Drug Excreted in Urine (Ae)Up to 4 Days
Urine PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
- Renal Clearance (CLr)Up to 4 Days
Urine PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302