A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects with Renal Impairment and in Healthy Subjects with Normal Renal Function

Phase 1

Recruiting

• Conditions: COVID 19
• Interventions: Drug: ALG-097558

• Registration Number: NCT06698549
• Lead Sponsor: Aligos Therapeutics

Brief Summary

This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with severe renal impairment and subjects without renal impairment, matched for age, body weight and, to the extent possible, for gender. The primary purpose of this study is to characterize the effect of renal impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily (Q12H) oral (PO) doses.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-21
• Study Start: 2025-02-01
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-11
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects with Severe Renal Impairment	ALG-097558	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
Subjects with Normal Renal Function	ALG-097558	Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
Subjects with Mild Renal Impairment (Optional)	ALG-097558	Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
Subjects with Moderate Renal Impairment (Optional)	ALG-097558	Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Primary Outcome Measures

Name	Time	Method
Area under the concentration time curve [AUC]	Pre-dose (-0.75 hours) up to Day 8	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Maximum plasma concentration [Cmax]	Pre-dose (-0.75 hours) up to Day 8	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Minimum plasma concentration [Cmin]	Pre-dose (-0.75 hours) up to Day 8	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
C0 [predose]	Pre-dose (-0.75 hours) up to Day 8	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Half-life [t1/2]	Pre-dose (-0.75 hours) up to Day 8	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time to maximum plasma concentration [Tmax]	Pre-dose (-0.75 hours) up to Day 8	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Apparent Clearance (CL/F)	Pre-dose (-0.75 hours) up to Day 8	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Apparent Volume of Distribution (V/F)	Pre-dose (-0.75 hours) up to Day 8	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Total Amount of Drug Excreted in Urine (Ae)	Pre-dose (-0.75 hours) up to Day 8	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine
Renal Clearance (CLr)	Pre-dose (-0.75 hours) up to Day 8	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Up to 20 Days	The number and severity of treatment emergent events in subjects with renal impairment and subjects with normal renal function as assessed by DAIDS v2.1 (July 2017)

Trial Locations

Locations (3)

University of Miami; 🇺🇸 Miami, Florida, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Genesis Clinical Trials; 🇺🇸 Tampa, Florida, United States