A Study Comparing LTG-001 SDD Formulation To LTG-001 Crystalline Immediate Release Tablets In Healthy Participants
NCT07341152 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2026-01-14
Summary
This is a single-center, open-label, part-randomized, crossover study in 14 healthy participants to assess the PK and safety profile of an SDD formulation of LTG-001 and two crystalline LTG-001 Instant Release tablet formulations, one of which will also be assessed at a differing dose level.
Conditions
- Pain Management
Interventions
- DRUG
-
LTG-001 SDD
LTG-001
- DRUG
-
LTG-001 Formulation A Prototype 1
LTG-001
- DRUG
-
LTG-001 Formulation B Prototype 2
LTG-001
- DRUG
-
LTG-001 Formulation B prototype 2
LTG-001 High Dose
Sponsors & Collaborators
-
Latigo Biotherapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-06
- Primary Completion
- 2025-11-17
- Completion
- 2025-11-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
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