PK of Deupirfenidone Versus Pirfenidone in Older Healthy Subjects

Conditions

• Pharmacokinetic Analysis

Eligibility Criteria

Sex

ALL

Age

60 Years - 80 Years

Healthy Volunteers

Accepted

Interventions

• Deupirfenidone — DRUG
  Swedish orange capsule
• Pirfenidone (PFD) — DRUG
  Swedish orange capsule
• Placebo — DRUG
  Swedish orange capsule

Study Details

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

Key Dates

Start date

Jul 12, 2021

Status verified

Mar 2026

Primary completion

Jan 1, 2022

Completion

Jan 20, 2022

Study Design

Enrollment

116 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Arms

• Experimental: Part 1 Active
  deupirfenidone 850 mg BID
• Active Comparator: Part 1 Active Comparator
  pirfenidone 801 mg TID
• Experimental: Part 2 Active
  deupirfenidone 550 mg TID
• Active Comparator: Part 2 Active Comparator
  pirfenidone 801 mg TID
• Experimental: Part 3 Active
  deupirfenidone 550/824 mg TID
• Placebo Comparator: Part 3 Placebo
  placebo TID

Primary Outcome Measure

Part 1: Cmax of BID deupirfenidone versus TID pirfenidone [ Time Frame: 14 days ]

Locations (3)

Find similar trials in Long Beach, CA