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

24 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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