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

NCT ID: NCT06672900

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-09
• Study Completion Date: 2025-07-07

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ALG-000184

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

Group Type: EXPERIMENTAL

ALG-000184

Intervention Type: DRUG

Study Investigational Product

Carbamazepine

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

Group Type: EXPERIMENTAL

Carbamazepine

Intervention Type: DRUG

Commercially available supply.

ALG-000184

Intervention Type: DRUG

Study Investigational Product

Itraconazole

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

Group Type: EXPERIMENTAL

Itraconazole (Sporanox)

Intervention Type: DRUG

Commercially available supply.

ALG-000184

Intervention Type: DRUG

Study Investigational Product

Interventions

Carbamazepine

Commercially available supply.

Intervention Type: DRUG

Itraconazole (Sporanox)

Commercially available supply.

Intervention Type: DRUG

ALG-000184

Study Investigational Product

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female between 18 and 55 years of age.

2. BMI 18.0 to 32.0 kg/m^2

3. Female participants must have a negative serum pregnancy test at screening.

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

Exclusion Criteria

1. 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.

2. 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.

3. Participants with a history of clinically significant drug allergy.

4. Participants with excessive use of alcohol defined as regular consumption of ≥14 standard drinks/week (US CDC 2022)

5. Participants that are unwilling to abstain from alcohol use for 1 week prior to start of the study through end of study follow up.

6. Participants with positive results for urine drug screen, alcohol or cotinine test at screening and Day -1.

7. Participants with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection.

8. Participants with sensitivity to CYP3A4 or P-gp substrates, inhibitors/inducers.

9. Participants with clinically significant abnormal vital signs or physical examination.

10. Participants with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73 m^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aligos Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PPD Austin Research Unit

Austin, Texas, United States

Countries

United States

Other Identifiers

ALG-000184-204

Identifier Type: -

Identifier Source: org_study_id