ALG-000184 Drug Interaction Study in Healthy Volunteers

Overseen By Jen Rito, Executive Director, Clinical Operations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Aligos Therapeutics

Must be taking: Itraconazole, Carbamazepine

Disqualifiers: Cardiac disease, Drug allergy, Alcohol use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a new drug, ALG-000184, interacts with other medications in healthy individuals. It consists of two parts: one tests ALG-000184 with Itraconazole, and the other with Carbamazepine. The goal is to understand the interactions between these drugs when taken together. This trial suits healthy volunteers who are not currently on medication and have no history of heart issues or substance use. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, since it involves drug interactions, you might need to discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that ALG-000184 is generally well-tolerated. Earlier research with both single and multiple doses found no major safety concerns, meaning participants did not report significant negative side effects. ALG-000184 is being tested for its effects on hepatitis B, and the safety results so far appear promising.

This is an early-stage study, so the treatment is still under careful safety evaluation. While ALG-000184 has been well-tolerated in past trials, new studies might reveal additional information. Always consult a healthcare provider with questions about joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ALG-000184 because it offers a new approach for treating Hepatitis B by acting as an HBV capsid assembly modulator. Unlike standard treatments that focus on inhibiting viral replication, ALG-000184 targets the assembly of the virus itself, potentially stopping it in its tracks much earlier in the process. This novel mechanism could complement existing therapies and enhance overall treatment effectiveness. Additionally, the study is assessing ALG-000184's interaction with drugs like carbamazepine and itraconazole, which could provide valuable insights into how it can be safely integrated with other treatments.

What evidence suggests that this trial's treatments could be effective?

Research shows that ALG-000184, a new treatment, holds promise for long-term hepatitis B (HBV) infections. Studies have found that this treatment can lower HBV DNA and RNA levels in patients, indicating reduced viral activity. ALG-000184 stops the virus from replicating, leading to the production of empty viral particles that can't cause infection. This method has undergone extensive study and is considered a strong approach to fighting HBV. Early trials showed significant drops in these viral markers, suggesting that ALG-000184 could effectively treat HBV.

This trial will study ALG-000184 for potential drug-drug interactions with Carbamazepine, a strong CYP3A4 inducer, and Itraconazole, a strong CYP3A4 inhibitor. Participants will receive either ALG-000184 alone or in combination with these drugs to evaluate any interactions. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

BMI 18.0 to 32.0 kg/m^2

Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria

I am a woman and my pregnancy test was negative.

Exclusion Criteria

Participants with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation

Participants with a history of clinically significant drug allergy

I have a history of heart rhythm problems or risk factors for severe arrhythmias.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive multiple doses of ALG-000184 and Itraconazole over a two week period to evaluate drug-drug interaction potential

2 weeks

Treatment Part 2

Participants receive multiple doses of ALG-000184 and ascending doses of Carbamazepine over an 18 day period to evaluate drug-drug interaction potential

18 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ALG-000184

Trial Overview 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.

How Is the Trial Designed?

Group I: Itraconazole Experimental Treatment 2 Interventions

Multiple doses of itraconazole, a strong CYP3A4 inhibitor, to evaluate potential drug-drug interactions with ALG-000184.

Group II: Carbamazepine Experimental Treatment 2 Interventions

Multiple doses of carbamazepine, a strong CYP3A4 inducer, to evaluate potential drug-drug interactions with ALG-000184

Group III: ALG-000184 Experimental Treatment 1 Intervention

Single or multiple doses of ALG-000184, an investigational HBV capsid assembly modulator

Who Is Running the Clinical Trial?

Aligos Therapeutics

Lead Sponsor

Trials

11

Recruited

960+

Founded

2018

Headquarters

South San Francisco, United States

Known For

Liver & Viral Therapies

Top Products

ALG-000184, ALG-055009, ALG-097558

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04536337

NCT04536337 | A Study of ALG-000184 Drug to Evaluate ... The goal of this clinical trial is to learn if ALG-000184 is safe, well-tolerated, and works to treat chronic hepatitis B virus (HBV) infection.

2. aligos.com aligos.com/wp-content/uploads/2023/02/3_ALG-000184_APASL-2023_Part-4-C1-2_Prof.-Hou_Clinical-Oral-Presentation.pdf

ALG-000184, a Capsid Assembly Modulator Capsid assembly modulators which produce empty viral particles (CAM-E) have been extensively studied for treating Chronic Hepatitis B (CHB). • CAM-E drugs ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39575679/

The Discovery and Preclinical Profile of ALG-000184, a ... ALG-000184 is currently being explored in multiple clinical trials in HBV-infected subjects where unprecedented reductions in HBV DNA, RNA and other viral ...

4. ctv.veeva.com ctv.veeva.com/study/a-phase-1-study-in-healthy-volunteers-to-evaluate-the-drug-drug-interaction-potential-of-multiple-do

A Multi-part Study of ALG-000184 to Evaluate Safety ... In Part 1, the drug-drug interaction (DDI) potential of ALG-000184 will be explored with Itraconazole; participants will be assigned to receive ...

5. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/supreme-trial-launches-alg-000184-chronic-hepatitis-b

Phase II B-SUPREME Trial Launches for ALG-000184 in ... The Phase II B-SUPREME trial involves 200 treatment-naïve adults with chronic HBV, comparing ALG-000184 to tenofovir disoproxil fumarate over 48 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06672900?term=ALG-000184.&rank=2

A Multi-part Study of ALG-000184 to Evaluate Safety, ... 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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04536337

NCT04536337 | A Study of ALG-000184 Drug to Evaluate ... The goal of this clinical trial is to learn if ALG-000184 is safe, well-tolerated, and works to treat chronic hepatitis B virus (HBV) infection.

8. aligos.com aligos.com/wp-content/uploads/2021/02/Safety-Tolerability-and-Pharmacokinetics-of-Single-Ascending-Doses-of-ALG-000184-a-Class-II-Capsid-Assembly-Modulator-for-the-Treatment-of-Chronic-Hepatitis-B-CHB-in-Healthy-Volunteers-HV.pdf

Safety, Tolerability and Pharmacokinetics of Single ... Here we report preliminary results from Part 1 of the ongoing first-in-human (FIH) phase 1a/1b dose-ranging study, ALG-000184-201. (ClinicalTrials.gov ...