NCT04993157

Pharmacokinetics Study of FIA586 in Participants With Mild and Moderate Hepatic Impairment

A Phase I, Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics, Safety, and Tolerability of FIA586 in Participants With Mild and Moderate Hepatic Impairment Compared to Matched Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I study designed to characterize the pharmacokinetics (PK), safety, and tolerability of a single oral dose of FIA586 in participants with mild and moderate hepatic impairment (HI) compared to matched healthy participants.The information obtained in this study will help to determine whether dosage adjustment for FIA586 is necessary in patients with advanced liver fibrosis who have mild to moderate HI.

Detailed description

This is a Phase I, single-dose, open-label, parallel-group study in participants with mild (Child-Pugh A; n=8-10) and moderate (Child-Pugh B; n=8-10) hepatic impairment (HI) and matched healthy participants with normal hepatic function (n=8-20). The study is comprised of an up to 28-day screening period (Days -28 to 2), a baseline evaluation (Day -1) prior to dosing on Day 1, and a treatment period of 6 days (Days 1-6). Participants will remain domiciled up to Day 6 after the Study Completion procedures have been completed. On Day 1, participants will be given a single dose of FIA586 following an overnight fast. PK (plasma and urine) and biomarker samples will be taken prior to dosing of study treatment and up to 120 hours (Day 6) post- dose. On Day 6, after the last PK sample has been taken, Study Completion assessments will be performed, and the participant will be discharged, provided there are no safety or tolerability concerns as judged by the investigator. All participants will have a post-study safety contact conducted approximately 30 days after administration of study treatment.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	FIA586	FIA586 capsule

Timeline

• Start date: 2021-12-10
• Primary completion: 2022-06-28
• Completion: 2022-06-28
• First posted: 2021-08-06
• Last updated: 2024-06-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study