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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetic Analysis
• Intervention / Treatment: Drug: Deupirfenidone; Drug: Pirfenidone (PFD); Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, LLC.
  • Florida
    • Lake Mary, Florida, United States, 32746
      • Accel Research Sites
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 Active; deupirfenidone 850 mg BID	Drug: Deupirfenidone; Swedish orange capsule; Other Names: LYT-100
Active Comparator: Part 1 Active Comparator; pirfenidone 801 mg TID	Drug: Pirfenidone (PFD); Swedish orange capsule
Experimental: Part 2 Active; deupirfenidone 550 mg TID	Drug: Deupirfenidone; Swedish orange capsule; Other Names: LYT-100
Active Comparator: Part 2 Active Comparator; pirfenidone 801 mg TID	Drug: Pirfenidone (PFD); Swedish orange capsule
Experimental: Part 3 Active; deupirfenidone 550/824 mg TID	Drug: Deupirfenidone; Swedish orange capsule; Other Names: LYT-100
Placebo Comparator: Part 3 Placebo; placebo TID	Drug: Placebo; Swedish orange capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Cmax of BID deupirfenidone versus TID pirfenidone	To compare the Cmax of 850 mg BID dosing of deupirfenidone to 801 mg TID dosing of pirfenidone at steady state, in older healthy subjects, when administered in a two-period crossover design.	14 days
Part 2: Cmax of TID deupirfenidone versus TID pirfenidone	To compare the Cmax of 550 mg TID deupirfenidone to 801 mg TID pirfenidone at steady state in older healthy subjects, when administered in a two-period crossover design.	14 days
Part 3: Cmax of TID deupirfenidone versus placebo	To evaluate the Cmax of two doses of deupirfenidone.	6 days
Part 1: AUC of BID deupirfenidone versus TID pirfenidone	To compare the AUC of 850 mg BID dosing of deupirfenidone to 801 mg TID dosing of pirfenidone at steady state, in older healthy subjects, when administered in a two-period crossover design.	14 Days
Part 1: Tmax of BID deupirfenidone versus TID pirfenidone	To compare the Tmax of 850 mg BID dosing of deupirfenidone to 801 mg TID dosing of pirfenidone at steady state, in older healthy subjects, when administered in a two-period crossover design.	14 Days
Part 2: AUC of TID deupirfenidone versus TID pirfenidone	To compare the AUC of 550 mg TID deupirfenidone to 801 mg TID pirfenidone at steady state in older healthy subjects, when administered in a two-period crossover design.	14 Days
Part 2: Tmax of TID deupirfenidone versus TID pirfenidone	To compare the Tmax of 550 mg TID deupirfenidone to 801 mg TID pirfenidone at steady state in older healthy subjects, when administered in a two-period crossover design.	14 Days
Part 3: AUC of TID deupirfenidone versus placebo	To evaluate the AUC of two doses of deupirfenidone.	6 Days
Part 3: PK profile of TID deupirfenidone versus placebo	To evaluate the Tmax of two doses of deupirfenidone.	6 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: The effect of food on the Cmax of BID deupirfenidone versus TID pirfenidone	To compare the Cmax of 850 mg BID dosing of deupirfenidone to 801 mg TID dosing of pirfenidone at steady state, in older healthy subjects, when administered with food on the last day of dosing prior to wash-out in a two-period crossover design.	1 day
Part 2: The effect of food on the Cmax of TID deupirfenidone versus TID pirfenidone	To compare the Cmax of 550 mg TID deupirfenidone to 801 mg TID pirfenidone at steady state in older healthy subjects, when administered with food on the last day of dosing prior to wash-out in a two-period crossover design.	1 day
Part 1: The effect of food on the AUC of BID deupirfenidone versus TID pirfenidone	To compare the AUC of 850 mg BID dosing of deupirfenidone to 801 mg TID dosing of pirfenidone at steady state, in older healthy subjects, when administered with food on the last day of dosing prior to wash-out in a two-period crossover design.	6 Days
Part 1: The effect of food on the Tmax of BID deupirfenidone versus TID pirfenidone	To compare the Tmax of 850 mg BID dosing of deupirfenidone to 801 mg TID dosing of pirfenidone at steady state, in older healthy subjects, when administered with food on the last day of dosing prior to wash-out in a two-period crossover design.	1 Day
Part 2: The effect of food on the AUC of TID deupirfenidone versus TID pirfenidone	To compare the AUC of 550 mg TID deupirfenidone to 801 mg TID pirfenidone at steady state in older healthy subjects, when administered with food on the last day of dosing prior to wash-out in a two-period crossover design.	1 Day
Part 2: The effect of food on the Tmax of TID deupirfenidone versus TID pirfenidone	To compare the Tmax of 550 mg TID deupirfenidone to 801 mg TID pirfenidone at steady state in older healthy subjects, when administered with food on the last day of dosing prior to wash-out in a two-period crossover design.	1 Day

Collaborators and Investigators

• Sponsor: PureTech
• Investigators: Principal Investigator: Steven H Reynolds, DO, Collaborative Neuroscience Network, LLC.; Principal Investigator: Michael A Hassman, DO, Hassman Research; Principal Investigator: Bruce G Rankin, DO, Accel Research Sites

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: elderly; pharmacokinetics; PK; pirfenidone; deupirfenidone
• Additional Relevant MeSH Terms: pirfenidone
• Other Study ID Numbers: LYT-100-2021-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This was a pharmacokinetic study with no health-based outcomes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No