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Completed

NCT Number: NCT07456800

PK of Deupirfenidone Versus Pirfenidone in Older Healthy Subjects

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

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Key information

Conditions

Pharmacokinetic Analysis

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Collaborative Neuroscience Network, LLC., Long Beach, California, United States

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About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Deupirfenidone

Drug

Swedish orange capsule

Other names: LYT-100

Pirfenidone (PFD)

Drug

Swedish orange capsule

Placebo

Drug

Swedish orange capsule

Primary outcomes

  1. Part 1: Cmax of BID deupirfenidone versus TID pirfenidone

    Time frame: 14 days

    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.

  2. Part 2: Cmax of TID deupirfenidone versus TID pirfenidone

    Time frame: 14 days

    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.

  3. Part 3: Cmax of TID deupirfenidone versus placebo

    Time frame: 6 days

    To evaluate the Cmax of two doses of deupirfenidone.

  4. Part 1: AUC of BID deupirfenidone versus TID pirfenidone

    Time frame: 14 Days

    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.

  5. Part 1: Tmax of BID deupirfenidone versus TID pirfenidone

    Time frame: 14 Days

    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.

  6. Part 2: AUC of TID deupirfenidone versus TID pirfenidone

    Time frame: 14 Days

    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.

  7. Part 2: Tmax of TID deupirfenidone versus TID pirfenidone

    Time frame: 14 Days

    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.

  8. Part 3: AUC of TID deupirfenidone versus placebo

    Time frame: 6 Days

    To evaluate the AUC of two doses of deupirfenidone.

  9. Part 3: PK profile of TID deupirfenidone versus placebo

    Time frame: 6 Days

    To evaluate the Tmax of two doses of deupirfenidone.

Secondary outcomes

  1. Part 1: The effect of food on the Cmax of BID deupirfenidone versus TID pirfenidone

    Time frame: 1 day

    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.

  2. Part 2: The effect of food on the Cmax of TID deupirfenidone versus TID pirfenidone

    Time frame: 1 day

    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.

  3. Part 1: The effect of food on the AUC of BID deupirfenidone versus TID pirfenidone

    Time frame: 6 Days

    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.

  4. Part 1: The effect of food on the Tmax of BID deupirfenidone versus TID pirfenidone

    Time frame: 1 Day

    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.

  5. Part 2: The effect of food on the AUC of TID deupirfenidone versus TID pirfenidone

    Time frame: 1 Day

    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.

  6. Part 2: The effect of food on the Tmax of TID deupirfenidone versus TID pirfenidone

    Time frame: 1 Day

    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.

Sponsors and collaborators

Lead sponsor

PureTech

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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