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Active, Not Recruiting

NCT Number: NCT06672900

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Austin Research Unit

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for All Participants:

  • 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.

Exclusion criteria

for All Participants:

  • 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)

Treatment and study plan

carbamazepine

Drug

Commercially available supply.

Itraconazole (Sporanox)

Drug

Commercially available supply.

ALG-000184

Drug

Study Investigational Product

Primary outcomes

  1. Area under the concentration time curve [AUC]

    Time frame: Up to 24 days

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

  2. Area under the concentration time curve [AUC]

    Time frame: Up to 29 days.

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

  3. Time to maximum plasma concentration [Tmax]

    Time frame: Up to 29 days

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

  4. Time to maximum plasma concentration [Tmax]

    Time frame: Up to 24 days

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

  5. Maximum plasma concentration [Cmax]

    Time frame: Up to 29 days

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

  6. Maximum plasma concentration [Cmax]

    Time frame: Up to 24 days

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

  7. Minimum plasma concentration [Cmin]

    Time frame: Up to 24 days

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

  8. Minimum plasma concentration [Cmin]

    Time frame: Up to 29 days

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

  9. C0 [predose]

    Time frame: Up to 24 days

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

  10. C0 [predose]

    Time frame: Up to 29 days

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

  11. Half-life [t1/2]

    Time frame: Up to 24 days

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

  12. Half-life [t1/2]

    Time frame: Up to 29 days

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

Secondary outcomes

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

    Time frame: Up to 24 days for Part 1

    The number and severity of treatment emergent adverse events in up to n=24 participants as assessed by DAIDS v2.1(July 2017)

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

    Time frame: Up to 29 days for Part 2

    The number and severity of treatment emergent adverse events in up to n=24 participants as assessed by DAIDS v2.1(July 2017)

  3. Mean Change from Baseline QTc at different exposure levels

    Time frame: Up to 24 days for Part 1.

    Evaluate the concentration-QT relationship of ALG-000175 and metabolite ALG-000302 to determine the QTc prolongation potential of ALG-000184.

  4. Mean Change from Baseline QTc at different exposure levels

    Time frame: Up to 29 days for Part 2.

    Evaluate the concentration-QT relationship of ALG-000175 and metabolite ALG-000302 to determine the QTc prolongation potential of ALG-000184.

Other outcomes

  1. Cholesterol

    Time frame: Up to 24 days in Part 1

    Intends to monitor plasma samples from baseline to measure 4-β-hydroxycholesterol, an induction marker of CYP450.

  2. Cholesterol

    Time frame: Up to 29 days in Part 2

    Intends to monitor plasma samples from baseline to measure 4-β-hydroxycholesterol, an induction marker of CYP450.

  3. Area under the concentration time curve [AUC]

    Time frame: 29 days

    Pharmacokinetic parameters of Carbamazepine and applicable metabolite

  4. Area under the concentration time curve [AUC]

    Time frame: 24 days

    Pharmacokinetic parameters of itraconazole and applicable metabolite

  5. Maximum plasma concentration [Cmax]

    Time frame: 24 days

    Pharmacokinetic parameters of Itraconazole and applicable metabolite

  6. Maximum plasma concentration [Cmax]

    Time frame: 29 days

    Pharmacokinetic parameters of Carbamazepine and applicable metabolite

  7. Minimum plasma concentration [Cmin]

    Time frame: 24 days

    Pharmacokinetic parameters of Itraconazole and applicable metabolite

  8. Minimum plasma concentration [Cmin]

    Time frame: 29 days

    Pharmacokinetic parameters of Carbamazepine and applicable metabolite

  9. C0 [predose]

    Time frame: 24 days

    Pharmacokinetic parameters of Itraconazole and applicable metabolite

  10. C0 [predose]

    Time frame: 29 days

    Pharmacokinetic parameters of Carbamazepine and applicable metabolite

  11. Half-life [t1/2]

    Time frame: 24 days

    Pharmacokinetic parameters of Itraconazole and applicable metabolite

  12. Half-life [t1/2]

    Time frame: 29 days

    Pharmacokinetic parameters of Carbamazepine and applicable metabolite

  13. Time to maximum plasma concentration [Tmax]

    Time frame: 24 Days

    Pharmacokinetic parameters of Itraconazole and applicable metabolite

  14. Time to maximum plasma concentration [Tmax]

    Time frame: 29 days

    Pharmacokinetic parameters of carbamazepine and applicable metabolite

Sponsors and collaborators

Lead sponsor

Aligos Therapeutics

Industry

Registry information

Official study title

A Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of Multiple Doses of ALG-000184.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 4, 2024
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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