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Atorvastatin with ALG-055009 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Aligos Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female between 18 and 65 years of age
Male subjects must agree to wear a condom during sexual intercourse and their female sexual partners should agree to use effective means of contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 23 days for part 1
Awards & highlights

Study Summary

This trial is divided into two parts and is being conducted on healthy volunteers. The goal of the study is to understand how a drug called ALG-055009 interacts with other medications. In both parts

Who is the study for?
This trial is for healthy individuals to study how ALG-055009 interacts with common cholesterol medications, specifically statins like Rosuvastatin and Atorvastatin. Participants will take multiple doses of ALG-055009 along with single doses of one statin.Check my eligibility
What is being tested?
The focus is on any interactions between a new drug, ALG-055009, and two widely used statins. The study has two parts where volunteers receive the new drug plus either Atorvastatin or Rosuvastatin to see if there are any changes in how these drugs work together.See study design
What are the potential side effects?
Since this trial involves healthy subjects and commonly used statins, side effects might include muscle pain, nausea, headache, dizziness which are typical for statin therapy; specific side effects related to ALG-055009 are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I agree to use a condom and my partner will use birth control during the trial.
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I am a woman capable of becoming pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 23 days for part 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 23 days for part 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration time curve [AUC]
C0 [predose]
Half-life [t1/2]
+3 more
Secondary outcome measures
Area under the concentration time curve [AUC] of 2-hydroxy-atorvastatin (ng/mL)
Area under the concentration time curve [AUC] of ALG-055009 (ng/mL)
Area under the concentration time curve [AUC] of ALG-055009 (ng/mL)PK
+14 more
Other outcome measures
Cholesterol

Trial Design

2Treatment groups
Experimental Treatment
Group I: Rosuvastatin with ALG-055009 (optional)Experimental Treatment2 Interventions
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).
Group II: Atorvastatin with ALG-055009Experimental Treatment2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rosuvastatin
2019
Completed Phase 4
~3150
Atorvastatin
1998
Completed Phase 4
~10900
ALG-055009
2021
Completed Phase 1
~100

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Aligos TherapeuticsLead Sponsor
7 Previous Clinical Trials
878 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the necessary criteria to be considered for enrollment in this clinical trial?

"To be eligible for enrollment in this research study, participants must meet the inclusion criteria of being healthy individuals aged between 18 and 65. The clinical trial aims to recruit approximately 27 suitable candidates."

Answered by AI

What are the anticipated results that researchers hope to achieve through conducting this study?

"As per the trial sponsor, Aligos Therapeutics, the primary objective of this study is to assess the Time to maximum plasma concentration [Tmax] over a duration of 22 days. Additionally, secondary outcomes will be evaluated including Minimum plasma concentration [Cmin] of 2-hydroxy-atorvastatin (ng/mL), which pertains to Pharmacokinetic parameters of 2-hydroxy-atorvastatin and relevant metabolites. The trial also aims to determine the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], measured by assessing the number and severity of treatment-related adverse events"

Answered by AI

Are there any ongoing efforts to enroll participants for this study at the moment?

"As per the information available on clinicaltrials.gov, this particular study is not actively seeking participants at the moment. It was initially posted on November 3rd, 2023 and last updated on December 20th, 2023. However, it's worth noting that there are currently a substantial number of other trials (specifically 755) that are actively enrolling patients."

Answered by AI

What is the level of safety associated with combining Atorvastatin and ALG-055009 for individuals?

"As this trial is in Phase 1, our team at Power rates the safety of Atorvastatin with ALG-055009 as a 1 due to limited available data supporting both safety and efficacy."

Answered by AI

Is the enrollment for this clinical trial open to individuals who are 75 years of age or older?

"Applicants who meet the eligibility criteria for this study must fall within the age range of 18 to 65. It is worth noting that there are a total of 57 trials available specifically for patients below the age of 18, and an additional 374 trials catered towards individuals over the age of 65."

Answered by AI

Who else is applying?

What site did they apply to?
PPD Austin Research Unit
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I want to help.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Phase 1 Study to Evaluate the Drug-Drug Interaction Potential Between ALG-055009 and Statin Therapy(Ies)
2023. "A Phase 1 Study to Evaluate the Drug-Drug Interaction Potential Between ALG-055009 and Statin Therapy(Ies)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06191991.
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