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PK of Deupirfenidone Versus Pirfenidone in Older Healthy Subjects

NCT07456800 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-03-06

No results posted yet for this study

Summary

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

Conditions

  • Pharmacokinetic Analysis

Interventions

DRUG

Placebo

Swedish orange capsule

DRUG

Deupirfenidone

Swedish orange capsule

DRUG

Pirfenidone (PFD)

Swedish orange capsule

Sponsors & Collaborators

Principal Investigators

  • Steven H Reynolds, DO · Collaborative Neuroscience Network, LLC.

  • Michael A Hassman, DO · Hassman Research

  • Bruce G Rankin, DO · Accel Research Sites

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2022-01-01
Completion
2022-01-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07456800 on ClinicalTrials.gov