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

NCT06717100 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-09

No results posted yet for this study

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 .

Conditions

  • Drug Interactions

Interventions

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.

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • PureTech

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-17
Primary Completion
2025-02-17
Completion
2025-03-17
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06717100 on ClinicalTrials.gov