A Phase 1 Study to Evaluate the Drug-Drug Interaction Potential Between ALG-055009 and Statin Therapy(Ies)
NCT06191991 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2025-02-17
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: atorvastatin (Part 1), or rosuvastatin (Part 2, optional).
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
40 mg
- DRUG
-
ALG-055009
0.9 mg
- DRUG
-
Rosuvastatin
10 mg
Sponsors & Collaborators
-
Aligos Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-11-03
- Primary Completion
- 2023-11-27
- Completion
- 2023-12-04
- FDA Drug
- Yes
Countries
- United States
Study Locations
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