NCT06717100

Study to Determine Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) and Nintedanib

A Phase 1 Study in Healthy Volunteers to Determine the Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) With Nintedanib

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: PureTech · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a trial of up to 60-day duration for safety, tolerability, and pharmacokinetics in healthy volunteers administered deupirfenidone (LYT-100) alone or in combination with nintedanib .

Detailed description

The purpose of this research is to investigate the effects of deupirfenidone (LYT-100) when co-administered with nintedanib to determine if there are any drug-drug interactions. In particular, the study will investigate the safety, tolerability and pharmacokinetics of LYT-100 co-administered with nintedanib. Eligible participants will be admitted to the Clinical Research Unit for 31 days, will be administered nintedanib and/or LYT-100 for 30 days, and will provide blood samples and have assessments during this time. Participants will return for a safety follow-up visit 30 days after taking the last dose of study drug.

Conditions

• Drug Interactions

Interventions

Type	Name	Description
DRUG	Nintedanib 150 MG [Ofev]	Nintedanib 150 MG will be administered every 12 hours from Days 1 to 20. LYT-100 will be titrated from 275 MG three times a day on Days 8 to 10, to 550 MG three times a day on Days 11 to 13, to 825 MG three times a day on Days 14 to 30.

Timeline

• Start date: 2024-12-17
• Primary completion: 2025-02-17
• Completion: 2025-03-17
• First posted: 2024-12-04
• Last updated: 2026-01-09

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study