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ALG-000184 Drug Interaction Study in Healthy Volunteers

Phase 1
Waitlist Available
Research Sponsored by Aligos Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female between 18 and 55 years of age
Female participants must have a negative serum pregnancy test at screening
Must not have
Participants with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc
Participants with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 29 days in part 2
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the interaction of a new drug called ALG-000184 with other drugs (Itraconazole and Carbamazepine) in healthy volunteers. The study will be

Who is the study for?
This clinical trial is for healthy individuals who want to help test how the new drug ALG-000184 interacts with other drugs. Participants will take multiple doses of ALG-000184 along with either Itraconazole or Carbamazepine over a period of two weeks to eighteen days.
What is being tested?
The study is testing the interaction between a new drug, ALG-000184, and two established drugs: Itraconazole and Carbamazepine. It's divided into two parts where volunteers receive these medications in combination to see if they affect each other when taken together.
What are the potential side effects?
Possible side effects may include reactions typical of taking ALG-000184, Itraconazole (Sporanox), or Carbamazepine such as nausea, headache, dizziness, or potential interactions that could alter the effectiveness or increase risks associated with either medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old.
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I am a woman and my pregnancy test was negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of heart rhythm problems or risk factors for severe arrhythmias.
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I have Hepatitis A, B, C, E, HIV-1/HIV-2, or an acute infection like COVID-19.
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I am sensitive to certain medications.
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I have no significant abnormal vital signs or physical issues.
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My kidney function is reduced, with a creatinine clearance rate below 90 mL/min.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 29 days in part 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 29 days in part 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Mean Change from Baseline QTc at different exposure levels
Other study objectives
Area under the concentration time curve [AUC]
C0 [predose]
Cholesterol
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: ItraconazoleExperimental Treatment2 Interventions
Multiple doses of itraconazole, a strong CYP3A4 inhibitor, to evaluate potential drug-drug interactions with ALG-000184.
Group II: CarbamazepineExperimental Treatment2 Interventions
Multiple doses of carbamazepine, a strong CYP3A4 inducer, to evaluate potential drug-drug interactions with ALG-000184
Group III: ALG-000184Experimental Treatment1 Intervention
Single or multiple doses of ALG-000184, an investigational HBV capsid assembly modulator
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carbamazepine
2016
Completed Phase 4
~2690
Itraconazole (Sporanox)
2015
Completed Phase 1
~20

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Aligos TherapeuticsLead Sponsor
10 Previous Clinical Trials
951 Total Patients Enrolled
~16 spots leftby Jul 2025
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