NCT07341152

A Study Comparing LTG-001 SDD Formulation To LTG-001 Crystalline Immediate Release Tablets In Healthy Participants

A Study to Assess the Pharmacokinetics and Relative Bioavailability of Crystalline LTG-001 Immediate Release Tablets Compared to LTG-001 SDD Formulation in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Latigo Biotherapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-10-06
• Primary completion: 2025-11-17
• Completion: 2025-11-17
• First posted: 2026-01-14
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study