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

NCT06672900 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ALG-000184-204
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy Volunteer; ALG-000184

Outcome Measures

Primary Outcomes (12)

• Area under the concentration time curve [AUC]

  Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1)

  Up to 24 days

• Area under the concentration time curve [AUC]

  Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)

  Up to 29 days.

• Time to maximum plasma concentration [Tmax]

  Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)

  Up to 29 days

• Time to maximum plasma concentration [Tmax]

  Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Itraconazole (Part 1)

  Up to 24 days

• Maximum plasma concentration [Cmax]

  Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)

  Up to 29 days

• Maximum plasma concentration [Cmax]

  Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Itraconazole (Part 1)

  Up to 24 days

• Minimum plasma concentration [Cmin]

  Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1)

  Up to 24 days

• Minimum plasma concentration [Cmin]

  Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)

  Up to 29 days

• C0 [predose]

  Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1)

  Up to 24 days

• C0 [predose]

  Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)

  Up to 29 days

• Half-life [t1/2]

  Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1)

  Up to 24 days

• Half-life [t1/2]

  Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)

  Up to 29 days

Secondary Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Up to 24 days for Part 1

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Up to 29 days for Part 2

• Mean Change from Baseline QTc at different exposure levels

  Up to 24 days for Part 1.

• Mean Change from Baseline QTc at different exposure levels

  Up to 29 days for Part 2.

Other Outcomes (14)

• Cholesterol

  Up to 24 days in Part 1

• Cholesterol

  Up to 29 days in Part 2

• Area under the concentration time curve [AUC]

  29 days

Study Arms (3)

ALG-000184

EXPERIMENTAL

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

Drug: ALG-000184

Carbamazepine

EXPERIMENTAL

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

Drug: Carbamazepine; Drug: ALG-000184

Itraconazole

EXPERIMENTAL

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

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

Interventions

Carbamazepine DRUG

Commercially available supply.

Carbamazepine

Itraconazole (Sporanox) DRUG

Commercially available supply.

Itraconazole

ALG-000184 DRUG

Study Investigational Product

ALG-000184; Carbamazepine; Itraconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between 18 and 55 years of age.
• BMI 18.0 to 32.0 kg/m\^2
• Female participants must have a negative serum pregnancy test at screening.
• Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria.

You may not qualify if:

• 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 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 a history of clinically significant drug allergy.
• Participants with excessive use of alcohol defined as regular consumption of ≥14 standard drinks/week (US CDC 2022)
• Participants that are unwilling to abstain from alcohol use for 1 week prior to start of the study through end of study follow up.
• Participants with positive results for urine drug screen, alcohol or cotinine test at screening and Day -1.
• Participants with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection.
• Participants with sensitivity to CYP3A4 or P-gp substrates, inhibitors/inducers.
• Participants with clinically significant abnormal vital signs or physical examination.
• 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)

Sponsors & Collaborators

• Aligos Therapeutics: lead

Study Sites (1)

PPD Austin Research Unit

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

Carbamazepine; Itraconazole

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, fixed sequence, crossover study.

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: November 4, 2024
• Study Start: January 9, 2025
• Primary Completion: July 7, 2025
• Study Completion: July 7, 2025
• Last Updated: February 3, 2025

Record last verified: 2024-11

Locations

US (1)