Clinical trial 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
Official title: A Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of Multiple Doses of ALG-000184.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
ALG-000184
Lead sponsor: Aligos Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, fixed sequence, crossover study.
Primary purpose: OTHER

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.


Eligibility 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)

Primary outcomes:
measure: Area under the concentration time curve [AUC]
timeFrame: Up to 24 days
measure: Area under the concentration time curve [AUC]
timeFrame: Up to 29 days.
measure: Time to maximum plasma concentration [Tmax]
timeFrame: Up to 29 days
measure: Time to maximum plasma concentration [Tmax]
timeFrame: Up to 24 days
measure: Maximum plasma concentration [Cmax]
timeFrame: Up to 29 days
measure: Maximum plasma concentration [Cmax]
timeFrame: Up to 24 days
measure: Minimum plasma concentration [Cmin]
timeFrame: Up to 24 days
measure: Minimum plasma concentration [Cmin]
timeFrame: Up to 29 days
measure: C0 [predose]
timeFrame: Up to 24 days
measure: C0 [predose]
timeFrame: Up to 29 days
measure: Half-life [t1/2]
timeFrame: Up to 24 days
measure: Half-life [t1/2]
timeFrame: Up to 29 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 24 days for Part 1
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 29 days for Part 2
measure: Mean Change from Baseline QTc at different exposure levels
timeFrame: Up to 24 days for Part 1.
measure: Mean Change from Baseline QTc at different exposure levels
timeFrame: Up to 29 days for Part 2.
Other outcomes:
measure: Cholesterol
timeFrame: Up to 24 days in Part 1
measure: Cholesterol
timeFrame: Up to 29 days in Part 2
measure: Area under the concentration time curve [AUC]
timeFrame: 29 days
measure: Area under the concentration time curve [AUC]
timeFrame: 24 days
measure: Maximum plasma concentration [Cmax]
timeFrame: 24 days
measure: Maximum plasma concentration [Cmax]
timeFrame: 29 days
measure: Minimum plasma concentration [Cmin]
timeFrame: 24 days
measure: Minimum plasma concentration [Cmin]
timeFrame: 29 days
measure: C0 [predose]
timeFrame: 24 days
measure: C0 [predose]
timeFrame: 29 days
measure: Half-life [t1/2]
timeFrame: 24 days
measure: Half-life [t1/2]
timeFrame: 29 days
measure: Time to maximum plasma concentration [Tmax]
timeFrame: 24 Days
measure: Time to maximum plasma concentration [Tmax]
timeFrame: 29 days
Locations:
city: Austin
country: United States
facility: PPD Austin Research Unit
state: Texas
Study officials:
References: