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

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

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.

• Male or female between 60 and 80 years old (inclusive) at the time of Screening.
• In good general health at Screening, free from clinically significant laboratory values, or clinically significant unstable medical, surgical, or psychiatric illness, as determined by the Investigator. Subjects with mild, chronic, stable disease and on stable medication could be included if deemed medically prudent by the Investigator.
• Has a body mass index (BMI) between ≥18.0 and ≤50.0 kg/m2 at Screening.