A Multi-part Study of ALG-000184 to Evaluate Safety, Tolerability, Pharmacokinetics and Drug-drug Interaction Potential After Single and Multiple Doses in Healthy Volunteers

Phase 1

Active, not recruiting

• Conditions: Healthy Volunteer
• Interventions: Drug: Carbamazepine; Drug: Itraconazole (Sporanox); Drug: ALG-000184

• Registration Number: NCT06672900
• Lead Sponsor: Aligos Therapeutics

Brief Summary

This Phase 1 study consists of two parts, all conducted in healthy volunteers (HVs).

In Part 1, the drug-drug interaction (DDI) potential of ALG-000184 will be explored with Itraconazole; participants will be assigned to receive multiple doses of ALG-000184 and Itraconazole over a two week period.

In Part 2, the drug-drug interaction (DDI) potential of ALG-000184 will be explored with Carbamazepine; participants will be assigned to receive multiple doses of ALG-000184 and ascending doses of Carbamazepine over an 18 day period.

The 2 parts may be conducted in parallel.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-25
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Study Start: 2025-01-09
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-07-07
• Study Completion: 2025-07-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbamazepine	Carbamazepine	Multiple doses of carbamazepine, a strong CYP3A4 inducer, to evaluate potential drug-drug interactions with ALG-000184
Carbamazepine	ALG-000184	Multiple doses of carbamazepine, a strong CYP3A4 inducer, to evaluate potential drug-drug interactions with ALG-000184
Itraconazole	Itraconazole (Sporanox)	Multiple doses of itraconazole, a strong CYP3A4 inhibitor, to evaluate potential drug-drug interactions with ALG-000184.
Itraconazole	ALG-000184	Multiple doses of itraconazole, a strong CYP3A4 inhibitor, to evaluate potential drug-drug interactions with ALG-000184.
ALG-000184	ALG-000184	Single or multiple doses of ALG-000184, an investigational HBV capsid assembly modulator

Primary Outcome Measures

Name	Time	Method
Minimum plasma concentration [Cmin]	Up to 29 days	Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)
C0 [predose]	Up to 29 days	Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)
Half-life [t1/2]	Up to 29 days	Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)
Maximum plasma concentration [Cmax]	Up to 24 days	Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Itraconazole (Part 1)
Area under the concentration time curve [AUC]	Up to 29 days.	Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)
Time to maximum plasma concentration [Tmax]	Up to 24 days	Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Itraconazole (Part 1)

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Up to 29 days for Part 2	The number and severity of treatment emergent adverse events in up to n=24 participants as assessed by DAIDS v2.1(July 2017)
Mean Change from Baseline QTc at different exposure levels	Up to 29 days for Part 2.	Evaluate the concentration-QT relationship of ALG-000175 and metabolite ALG-000302 to determine the QTc prolongation potential of ALG-000184.

Trial Locations

Locations (1)

PPD Austin Research Unit; 🇺🇸 Austin, Texas, United States