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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
Sponsor: Aligos Therapeutics
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.
Official title: A Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of Multiple Doses of ALG-000184.
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-01-09
Completion Date
2025-07-07
Last Updated
2025-02-03
Healthy Volunteers
Yes
Conditions
Interventions
Carbamazepine
Commercially available supply.
Itraconazole (Sporanox)
Commercially available supply.
ALG-000184
Study Investigational Product
Locations (1)
PPD Austin Research Unit
Austin, Texas, United States