PK of Deupirfenidone Versus Pirfenidone in Older Healthy Subjects

PureTech116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

116

Conditions

Pharmacokinetic Analysis

Interventions

DeupirfenidoneDRUG

Swedish orange capsule

Pirfenidone (PFD)DRUG

Swedish orange capsule

PlaceboDRUG

Swedish orange capsule

Eligibility

Sex: ALLMin age: 60 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

* 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.

Locations (3)

Collaborative Neuroscience Network, LLC.

Long Beach, California, United States

Accel Research Sites

Lake Mary, Florida, United States

Hassman Research

Berlin, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 14 days

Part 3: Cmax of TID deupirfenidone versus placebo

To evaluate the Cmax of two doses of deupirfenidone.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 1 Day