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
NCT06672900 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-02-03
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.
Conditions
- Healthy Volunteer
Interventions
- DRUG
-
Carbamazepine
Commercially available supply.
- DRUG
-
Itraconazole (Sporanox)
Commercially available supply.
- DRUG
-
ALG-000184
Study Investigational Product
Sponsors & Collaborators
-
Aligos Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-01-09
- Primary Completion
- 2025-07-07
- Completion
- 2025-07-07
- FDA Drug
- Yes
Countries
- United States
Study Locations
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