Healthy VolunteersPhase 1NCT06191991
A Phase 1 Study to Evaluate the Drug-Drug Interaction Potential Between ALG-055009 and Statin Therapy(Ies)
A Phase 1 study testing Atorvastatin, ALG-055009 and Rosuvastatin in people with Healthy Volunteers, 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 Parts 1 and 2, the drug-drug interaction (DDI) potential of ALG-055009 will be explored, where subjects will be assigned to receive multiple doses of ALG-055009 and 2 single doses of one of the following concomitant drugs… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Atorvastatin, ALG-055009 and Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2023to 4 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- In the Investigator's opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned.
- Male or female between 18 and 65 years of age, extremes included.
- Female subjects must not be a woman of childbearing potential defined as:
- Postmenopausal:
- A postmenopausal state is defined as no menses for at least 12 months without an alternative medical explanation, confirmed by a high follicle-stimulating hormone (FSH) level in the postmenopausal range at screening.
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- OR
- Permanently sterile:
- Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
- Male subjects must agree to wear a condom during sexual intercourse and their female sexual partners should agree to use effective means of contraception (Section 7.2.3). These contraceptive measures must be implemented, at a minimum, from the start of dosing until at least 90 days after the last dose.
- NOTE: Contraceptive use should be consistent with local regulations regarding the use of contraceptive methods for subjects participating in clinical studies.
- Subjects must have a body mass index (BMI) of 18.0 to 32.0 kg/m2, extremes included.
- Subjects must be nonsmokers for at least 3 months prior to enrollment.
- Subjects must have a 12-lead electrocardiogram (ECG) that meets the following criteria at screening:
- Heart rate between 40 and 100 beats per minute [bpm], extremes included;
- QT interval corrected for heart rate (QTc) according to Fridericia's formula (QTcF) <450 ms (males) or <470 ms (females);
- QRS interval <120 ms;
- PR interval ≥110 to ≤220 ms;
- In addition to fulfilling the above ECG criteria, ECG morphology must have no clinically significant abnormalities observed.
- Subjects must be deemed to be in good overall health by the Investigator on the basis of a medical evaluation that reveals the absence of any clinically significant abnormality and includes a physical examination, medical history, vital signs, and the results of blood chemistry, blood coagulation and hematology tests, and a urinalysis performed at screening.
- Subject must be willing and able to adhere to the Prohibited Medication requirements (Appendix B) and Special Precautions (Section 6.12).
Who cannot join
- Subject with a) a medical history of thyroid disorder or b) abnormal thyroid stimulating hormone (TSH), free thyroxine (T4) or total triiodothyronine (T3) during screening, and Day -1 or c) known sensitivity to thyroid medications.
- The following laboratory values at screening are exclusionary:
- ALT or AST > upper limit of normal (ULN),
- Total bilirubin >1.2× ULN, unless Gilbert's Syndrome is suspected
- Subjects 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. This may include, but is not limited to, renal, cardiac, vascular, pulmonary, gastrointestinal, hepatologic, endocrine, neurologic, dermatologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances.
- Subjects 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 such as: angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, clinically significant ECG abnormalities, moderate to severe valvular disease or uncontrolled hypertension. Evidence on ECG of heart block or bundle branch block, inclusive of first-degree AV block and incomplete bundle branch block, is also exclusionary.
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- History of unexplained syncope.
- Subjects with a history of clinically significant (in the opinion of the Investigator) drug allergy such as, but not limited to, sulfonamides or drug allergy witnessed in previous studies with experimental drugs.
- Subjects with a recent (within 1 year of enrollment) history or current evidence of use of amphetamines, barbiturates, narcotic or other drugs of abuse/recreational drug use (including cannabis).
- Excessive use of alcohol defined as regular consumption of ≥14 standard drinks/week for women and ≥21 standard drinks/week for men (Chalasani et al. 2018). For current definition of a standard drink, please refer to the National Institute on Alcohol Abuse and Alcoholism website (https://www.niaaa.nih.gov/what-standard-drink).
- Unwilling to abstain from alcohol use for 1 week prior to start of study through end of study follow up.
- Positive results for urine drug screen, alcohol or cotinine test at screening and Day -1.
- Subjects with current:
- Hepatitis A virus infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]).
- Hepatitis B infection defined as presence of HBsAg or HBV core antibody.
- Hepatitis C virus (HCV) infection (confirmed by HCV antibody and/or HCV RNA).
- Hepatitis E virus: Anti-HEV IgM-positive and/or detectable HEV RNA level.
- Human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening.
- Acute infection at the time of enrollment. If an acute infection is considered resolved prior to enrollment, the subject remains eligible.
- Male subjects who plan to father a child while enrolled in this study or within 90 days after the last dose of study drug.
- Subject receiving, or urgently requiring, any lipid lowering therapy (e.g., statins). Prior use (at least 1 month prior to screening) of lipid lowering therapy is not exclusionary.
- Subject who has taken or requires treatment with any disallowed therapies as noted in Prohibited Medications (Appendix B) and Special Precautions (Section 6.12) within 1 week or 5 half-lives (whichever is longer) before the planned first dose of study drug or during dosing; use of sensitive CYP3A4 substrates, inhibitors/inducers of CYP3A4, inhibitors of OATP1B1, OATP1B3, and/or BCRP transporters (see Appendix B), within 28 days or 5 half-lives (whichever is longer) prior to the first dose of study drug is prohibited.
- Consumption of grapefruit, grapefruit juice, and Seville oranges within 14 days prior to study drug administration.
- Consumption of apple or orange juice, citrus fruits, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), and charbroiled meats within 7 days prior to study drug administration.
- Consumption of any food or drink/beverage containing quinine (e.g., tonic, bitter lemon, bitter alcoholic beverages containing quinine) within 24 hours prior to study drug administration.
- Consumption of any food or drink/beverage containing poppy seeds or codeine containing formulation within 72 hours of screening and admission to study site.
- Known hypersensitivity or previous adverse events (AEs) with atorvastatin, rosuvastatin or other statins.
- Subjects who received an investigational agent within 4 weeks (or 5 half-lives, whichever is longer) prior to enrollment.
- Subjects currently participating in another clinical or medical interventional research study.
- Subjects with any laboratory result that is considered clinically significant by the Investigator at screening. Abnormal values of ALT, AST, total bilirubin, TSH, free T4, and total T3 are exclusionary regardless of any clinical significance assessment by the Investigator (see Exclusion Criteria 1 and 2).
- Clinically significant abnormal vital signs (evaluated in the supine position after 5 minutes of rest), confirmed with retesting after at least 5 minutes of additional rest and at the discretion of the PI. Vital sign reference ranges to assess eligibility are as follows:
- Systolic blood pressure: >90 to ≤140 mmHg
- Diastolic blood pressure: ≥45 to ≤90 mmHg
- Pulse rate: ≥40 to ≤100 beats per minute
- Physical examination findings that are considered clinically significant in the opinion of the Investigator and likely to adversely impact study conduct and/or interpretation are exclusionary.
- Subjects who had major surgery (e.g., requiring general anesthesia) within 12 weeks before enrollment, or will not have fully recovered from surgery, or have surgery planned during the time the subject is expected to participate in the study, or within 4 weeks after the last dose of study drug.
- Subjects with renal dysfunction [e.g., estimated creatinine clearance <80 mL/min/1.73 m2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula]. CKD-EPI should not be corrected for subjects of African ancestry.
- Subject is an employee of the Sponsor, the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, as well as family members of the employees or the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential Between ALG-055009 and Statin Therapy(Ies)
This Phase 1 study consists of two parts, all conducted in healthy volunteers (HVs). In Parts 1 and 2, the drug-drug interaction (DDI) potential of ALG-055009 will be explored, where subjects will be assigned to receive multiple doses of ALG-055009 and 2 single doses of one of the following concomitant drugs: atorvastatin (Part 1), or rosuvastatin (Part 2, optional).
- Conditions
- Healthy Volunteers
- Being tested
- Atorvastatin, ALG-055009, Rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
40 mg
ALG-055009Drug
0.9 mg
RosuvastatinDrug
10 mg
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin with ALG-055009 | Experimental | Single dose PO administration of 40 mg atorvastatin (Day 1), then a washout period of at least 2 days, followed by PO QD administration of 0.9 mg ALG-055009 for 14 days (Days 3-16) and single dose PO administration of 40 mg atorvastatin (Day 15). Receives: Drug: Atorvastatin; Drug: ALG-055009 |
| Rosuvastatin with ALG-055009 (optional) | Experimental | Single dose PO administration of 10 mg rosuvastatin (Day 1), then a washout period of at least 4 days, followed by PO QD administration of 0.9 mg ALG-055009 for 11 days (Days 5-15) and single dose PO administration of 10 mg rosuvastatin (Day 11). Receives: Drug: ALG-055009; Drug: Rosuvastatin |
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 atorvastatin and applicable metabolites
Measured: 23 days
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Measured: 23 days
Maximum plasma concentration [Cmax]
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Measured: 23 days
Minimum plasma concentration [Cmin]
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Measured: 23 days
C0 [predose]
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Measured: 23 days
Half-life [t1/2]
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Measured: 23 days
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Measured: 22 days
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Measured: 22 days
Maximum plasma concentration [Cmax]
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Measured: 22 days
Minimum plasma concentration [Cmin]
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Measured: 22 days
C0 [predose]
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Measured: 22 days
Half-life [t1/2]
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Measured: 22 days
Secondary outcomes (21)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: up to 23 days for part 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: Up to 22 days for part 2
Time to maximum plasma concentration [Cmax] of ALG-055009 (ng/mL)
Pharmacokinetic parameters of ALG-055009 and applicable metabolites
Measured: up to 23 days for part 1
Minimum plasma concentration [Cmin] of ALG-055009 (ng/mL)
Pharmacokinetic parameters of ALG-055009 and applicable
Measured: up to 23 days for part 1
Area under the concentration time curve [AUC] of ALG-055009 (ng/mL)PK
Pharmacokinetic parameters of ALG-055009 and applicable metabolites
Measured: up to 23 days for part 1
Time to maximum plasma concentration [Tmax] of ALG-055009 (ng/mL)
Pharmacokinetic parameters of ALG-055009 and applicable metabolites
Measured: up to 23 days for part 1
Half-life [t1/2] of ALG-055009 (ng/mL)
Pharmacokinetic parameters of ALG-055009 and applicable metabolites
Measured: up to 23 days for part 1
Time to maximum plasma concentration [Cmax] of 2-hydroxy-atorvastatin (ng/mL)
Pharmacokinetic parameters of 2-hydroxy-atorvastatin and applicable
Measured: up to 23 days for part 1
Minimum plasma concentration [Cmin] of 2-hydroxy-atorvastatin (ng/mL)
Pharmacokinetic parameters of 2-hydroxy-atorvastatin and applicable metabolites
Measured: up to 23 days for part 1
Area under the concentration time curve [AUC] of 2-hydroxy-atorvastatin (ng/mL)
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Measured: up to 23 days for part 1
Time to maximum plasma concentration [Tmax] of 2-hydroxy-atorvastatin (ng/mL)
Pharmacokinetic parameters of 2-hydroxy-atorvastatin and applicable metabolites
Measured: up to 23 days for part 1
Half-life [t1/2] of 2-hydroxy-atorvastatin (ng/mL)
Time to maximum plasma concentration [Cmax] of ALG-055009 (ng/mL)
Measured: up to 23 days for part 1
Minimum plasma concentration [Cmin] of ALG-055009 (ng/mL)
Pharmacokinetic parameters of ALG-055009 and applicable metabolites
Measured: up to 22 days for part 2
Area under the concentration time curve [AUC] of ALG-055009 (ng/mL)
Pharmacokinetic parameters of ALG-055009 and applicable metabolites
Measured: up to 22 days for part 2
Time to maximum plasma concentration [Tmax] of ALG-055009 (ng/mL)
Pharmacokinetic parameters of ALG-055009 and applicable metabolites
Measured: up to 22 days for part 2
Half-life [t1/2] of ALG-055009 (ng/mL)
Pharmacokinetic parameters of ALG-055009 and applicable metabolites
Measured: up to 22 days for part 2
Time to maximum plasma concentration [Cmax] of rosuvastatin (ng/mL)
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Measured: up to 22 days for part 2
Minimum plasma concentration [Cmin] of rosuvastatin (ng/mL)
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Measured: up to 22 days for part 2
Area under the concentration time curve [AUC] of rosuvastatin (ng/mL)
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Measured: up to 22 days for part 2
Time to maximum plasma concentration [Tmax] of rosuvastatin (ng/mL
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Measured: up to 22 days for part 2
Half-life [t1/2] of rosuvastatin (ng/mL)
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Measured: up to 22 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 posted5 Jan 2024
- Study start3 Nov 2023
- Primary completion27 Nov 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT06191991
- Sponsor's protocol ID
- ALG-055009-302
- Status last verified
- Feb 2025
- First submitted
- 3 Nov 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential Between ALG-055009 and Statin Therapy(Ies)
- ClinicalTrials.gov ID
- NCT06191991
- Acronym / sponsor ID
- ALG-055009-302
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Aligos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 5 Jan 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 Parts 1 and 2, the drug-drug interaction (DDI) potential of ALG-055009 will be explored, where subjects will be assigned to receive multiple doses of ALG-055009 and 2 single doses of one of the following concomitant drugs: atorvastatin (Part 1), or rosuvastatin (Part 2, optional).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin with ALG-055009 | Experimental | Drug: Atorvastatin, Drug: ALG-055009Single dose PO administration of 40 mg atorvastatin (Day 1), then a washout period of at least 2 days, followed by PO QD administration of 0.9 mg ALG-055009 for 14 days (Days 3-16) and single dose PO administration of 40 mg atorvastatin (Day 15). |
| Rosuvastatin with ALG-055009 (optional) | Experimental | Drug: ALG-055009, Drug: RosuvastatinSingle dose PO administration of 10 mg rosuvastatin (Day 1), then a washout period of at least 4 days, followed by PO QD administration of 0.9 mg ALG-055009 for 11 days (Days 5-15) and single dose PO administration of 10 mg rosuvastatin (Day 11). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- In the Investigator's opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned.
- Male or female between 18 and 65 years of age, extremes included.
- Female subjects must not be a woman of childbearing potential defined as:
- A postmenopausal state is defined as no menses for at least 12 months without an alternative medical explanation, confirmed by a high follicle-stimulating hormone (FSH) level in the postmenopausal range at screening.
Key exclusion criteria (38 listed)
- Subject with a) a medical history of thyroid disorder or b) abnormal thyroid stimulating hormone (TSH), free thyroxine (T4) or total triiodothyronine (T3) during screening, and Day -1 or c) known sensitivity to thyroid medications.
- The following laboratory values at screening are exclusionary:
- Subjects 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. This may include, but is not limited to, renal, cardiac, vascular, pulmonary, gastrointestinal, hepatologic, endocrine, neurologic, dermatologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances.
- Subjects 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 such as: angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, clinically significant ECG abnormalities, moderate to severe valvular disease or uncontrolled hypertension. Evidence on ECG of heart block or bundle branch block, inclusive of first-degree AV block and incomplete bundle branch block, is also exclusionary.
- History of unexplained syncope.
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 |
|---|---|---|
| Atorvastatin40 mg | Drug | Atorvastatin with ALG-055009 |
| ALG-0550090.9 mg | Drug | Atorvastatin with ALG-055009, Rosuvastatin with ALG-055009 (optional) |
| Rosuvastatin10 mg | Drug | Rosuvastatin with ALG-055009 (optional) |
Primary outcome
Area under the concentration time curve [AUC]
Time frame: 23 days
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Time to maximum plasma concentration [Tmax]
Time frame: 23 days
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Maximum plasma concentration [Cmax]
Time frame: 23 days
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Minimum plasma concentration [Cmin]
Time frame: 23 days
Pharmacokinetic parameters of atorvastatin and applicable metabolites
C0 [predose]
Time frame: 23 days
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Half-life [t1/2]
Time frame: 23 days
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Area under the concentration time curve [AUC]
Time frame: 22 days
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Time to maximum plasma concentration [Tmax]
Time frame: 22 days
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Maximum plasma concentration [Cmax]
Time frame: 22 days
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Minimum plasma concentration [Cmin]
Time frame: 22 days
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
C0 [predose]
Time frame: 22 days
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Half-life [t1/2]
Time frame: 22 days
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
21 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: up to 23 days for part 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 22 days for part 2
Time to maximum plasma concentration [Cmax] of ALG-055009 (ng/mL)
Time frame: up to 23 days for part 1
Minimum plasma concentration [Cmin] of ALG-055009 (ng/mL)
Time frame: up to 23 days for part 1
Area under the concentration time curve [AUC] of ALG-055009 (ng/mL)PK
Time frame: up to 23 days for part 1
Time to maximum plasma concentration [Tmax] of ALG-055009 (ng/mL)
Time frame: up to 23 days for part 1
Half-life [t1/2] of ALG-055009 (ng/mL)
Time frame: up to 23 days for part 1
Time to maximum plasma concentration [Cmax] of 2-hydroxy-atorvastatin (ng/mL)
Time frame: up to 23 days for part 1
Minimum plasma concentration [Cmin] of 2-hydroxy-atorvastatin (ng/mL)
Time frame: up to 23 days for part 1
Area under the concentration time curve [AUC] of 2-hydroxy-atorvastatin (ng/mL)
Time frame: up to 23 days for part 1
Time to maximum plasma concentration [Tmax] of 2-hydroxy-atorvastatin (ng/mL)
Time frame: up to 23 days for part 1
Half-life [t1/2] of 2-hydroxy-atorvastatin (ng/mL)
Time frame: up to 23 days for part 1
Minimum plasma concentration [Cmin] of ALG-055009 (ng/mL)
Time frame: up to 22 days for part 2
Area under the concentration time curve [AUC] of ALG-055009 (ng/mL)
Time frame: up to 22 days for part 2
Time to maximum plasma concentration [Tmax] of ALG-055009 (ng/mL)
Time frame: up to 22 days for part 2
Half-life [t1/2] of ALG-055009 (ng/mL)
Time frame: up to 22 days for part 2
Time to maximum plasma concentration [Cmax] of rosuvastatin (ng/mL)
Time frame: up to 22 days for part 2
Minimum plasma concentration [Cmin] of rosuvastatin (ng/mL)
Time frame: up to 22 days for part 2
Area under the concentration time curve [AUC] of rosuvastatin (ng/mL)
Time frame: up to 22 days for part 2
Time to maximum plasma concentration [Tmax] of rosuvastatin (ng/mL
Time frame: up to 22 days for part 2
Half-life [t1/2] of rosuvastatin (ng/mL)
Time frame: up to 22 days for part 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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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 Atorvastatin, ALG-055009 and Rosuvastatin in people with Healthy Volunteers, 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 21 inclusion and 38 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: finished, as of the sponsor's last update on 17 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 23 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 17 Feb 2025.