NCT07456800

PK of Deupirfenidone Versus Pirfenidone in Older Healthy Subjects

A Phase 1, Double-Blind, Randomized, Crossover Study in Older Healthy Subjects to Compare the Safety, Tolerability, and Pharmacokinetics of Lyt-100 (Deupirfenidone) to Pirfenidone

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: PureTech · Industry
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Accepted

Summary

A three-part, randomized, double-blind study in healthy older adults to identify a dose of deupirfenidone for further clinical study.

Detailed description

A Phase 1 study to evaluate safety, tolerability, and PK in older healthy subjects of multiple twice daily (BID) or 3 times daily (TID) doses of deupirfenidone administered over 3 days compared to that of pirfenidone or placebo administered TID. The study also investigated the PK profile of deupirfenidone at steady state compared to that of pirfenidone at steady state and the effect of food on the PK profile of deupirfenidone and pirfenidone. The study was conducted in 3 parts. Part 1 was a randomized, double-blinded, two-period crossover study conducted in healthy older adults to evaluate the tolerability differentiation of BID dosing of deupirfenidone to pirfenidone. Part 2 was a randomized, double-blinded, two-period crossover study conducted in healthy older adults to evaluate the tolerability differentiation of TID dosing of deupirfenidone to pirfenidone. Part 3 was a randomized, double-blinded, parallel arm, placebo-controlled study conducted in healthy older adults to evaluate the safety and tolerability of two doses of deupirfenidone.

Conditions

• Pharmacokinetic Analysis

Interventions

Type	Name	Description
DRUG	Deupirfenidone	Swedish orange capsule
DRUG	Pirfenidone (PFD)	Swedish orange capsule
DRUG	Placebo	Swedish orange capsule

Timeline

• Start date: 2021-07-12
• Primary completion: 2022-01-01
• Completion: 2022-01-20
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study