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

Aligos Therapeutics

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Itraconazole (Sporanox); Drug: ALG-000184; Drug: Carbamazepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06672900

ALG-000184-204

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for All Participants:

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 for All Participants:

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

ALG-000184

Experimental group

Description:

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

Treatment:

Drug: ALG-000184

Carbamazepine

Experimental group

Description:

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

Treatment:

Drug: Carbamazepine

Drug: ALG-000184

Itraconazole

Experimental group

Description:

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

Treatment:

Drug: ALG-000184

Drug: Itraconazole (Sporanox)