Healthy VolunteerPhase 1NCT06672900
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
A Phase 1 study testing Carbamazepine, Itraconazole (Sporanox) and ALG-000184 in people with Healthy Volunteer, run by Aligos Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Carbamazepine, Itraconazole (Sporanox) and ALG-000184
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2025to 7 Jul 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of Multiple Doses of ALG-000184.
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
- Being tested
- Carbamazepine, Itraconazole (Sporanox), ALG-000184
- Keywords
- Healthy Volunteer, ALG-000184
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbamazepineDrug
Commercially available supply.
Itraconazole (Sporanox)Drug
Commercially available supply.
ALG-000184Drug
Study Investigational Product
| Study group | Role | What they receive |
|---|---|---|
| ALG-000184 | Experimental | Single or multiple doses of ALG-000184, an investigational HBV capsid assembly modulator Receives: Drug: ALG-000184 |
| Carbamazepine | Experimental | Multiple doses of carbamazepine, a strong CYP3A4 inducer, to evaluate potential drug-drug interactions with ALG-000184 Receives: Drug: Carbamazepine; Drug: ALG-000184 |
| Itraconazole | Experimental | Multiple doses of itraconazole, a strong CYP3A4 inhibitor, to evaluate potential drug-drug interactions with ALG-000184. Receives: Drug: Itraconazole (Sporanox); Drug: ALG-000184 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Up to 24 days
Maximum plasma concentration [Cmax]
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)
Measured: Up to 29 days
Maximum plasma concentration [Cmax]
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Itraconazole (Part 1)
Measured: Up to 24 days
Minimum plasma concentration [Cmin]
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1)
Measured: Up to 24 days
Minimum plasma concentration [Cmin]
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)
Measured: Up to 29 days
C0 [predose]
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1)
Measured: Up to 24 days
C0 [predose]
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)
Measured: Up to 29 days
Half-life [t1/2]
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1)
Measured: Up to 24 days
Half-life [t1/2]
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)
Measured: Up to 29 days
Secondary outcomes (4)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events in up to n=24 participants as assessed by DAIDS v2.1(July 2017)
Measured: Up to 24 days for Part 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events in up to n=24 participants as assessed by DAIDS v2.1(July 2017)
Measured: Up to 29 days for Part 2
Mean Change from Baseline QTc at different exposure levels
Evaluate the concentration-QT relationship of ALG-000175 and metabolite ALG-000302 to determine the QTc prolongation potential of ALG-000184.
Measured: Up to 24 days for Part 1.
Mean Change from Baseline QTc at different exposure levels
Evaluate the concentration-QT relationship of ALG-000175 and metabolite ALG-000302 to determine the QTc prolongation potential of ALG-000184.
Measured: Up to 29 days for Part 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start9 Jan 2025
- Primary completion7 Jul 2025 (estimated)
- Study completion7 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, fixed sequence, crossover study.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aligos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672900
- Sponsor's protocol ID
- ALG-000184-204
- Status last verified
- Nov 2024
- First submitted
- 25 Sep 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of Multiple Doses of ALG-000184.
- ClinicalTrials.gov ID
- NCT06672900
- Acronym / sponsor ID
- ALG-000184-204
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ALG-000184
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aligos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 7 Jul 2025 (estimated)
- Study completion
- 7 Jul 2025 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open-label, fixed sequence, crossover study.
| Arm | Type | Receives |
|---|---|---|
| ALG-000184 | Experimental | Drug: ALG-000184Single or multiple doses of ALG-000184, an investigational HBV capsid assembly modulator |
| Carbamazepine | Experimental | Drug: Carbamazepine, Drug: ALG-000184Multiple doses of carbamazepine, a strong CYP3A4 inducer, to evaluate potential drug-drug interactions with ALG-000184 |
| Itraconazole | Experimental | Drug: Itraconazole (Sporanox), Drug: ALG-000184Multiple doses of itraconazole, a strong CYP3A4 inhibitor, to evaluate potential drug-drug interactions with ALG-000184. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarbamazepineCommercially available supply. | Drug | Carbamazepine |
| Itraconazole (Sporanox)Commercially available supply. | Drug | Itraconazole |
| ALG-000184Study Investigational Product | Drug | ALG-000184, Carbamazepine, Itraconazole |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
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)
C0 [predose]
Time frame: Up to 24 days
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1)
C0 [predose]
Time frame: Up to 29 days
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)
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)
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)
4 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 24 days for Part 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 29 days for Part 2
Mean Change from Baseline QTc at different exposure levels
Time frame: Up to 24 days for Part 1.
Mean Change from Baseline QTc at different exposure levels
Time frame: Up to 29 days for Part 2.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Carbamazepine, Itraconazole (Sporanox) and ALG-000184 in people with Healthy Volunteer, run by Aligos Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration time curve [AUC] (time frame: Up to 24 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.