CompletedPhase 1

PK of Deupirfenidone Versus Pirfenidone in Older Healthy Subjects

United States116 participantsStarted 2021-07-12

Plain-language summary

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

Who can participate

Age range60 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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.

What they're measuring

Part 1: Cmax of BID deupirfenidone versus TID pirfenidone

Timeframe: 14 days

Part 2: Cmax of TID deupirfenidone versus TID pirfenidone

Timeframe: 14 days

Part 3: Cmax of TID deupirfenidone versus placebo

Timeframe: 6 days

Part 1: AUC of BID deupirfenidone versus TID pirfenidone

Timeframe: 14 Days

Part 1: Tmax of BID deupirfenidone versus TID pirfenidone

Timeframe: 14 Days

Part 2: AUC of TID deupirfenidone versus TID pirfenidone

Timeframe: 14 Days

Part 2: Tmax of TID deupirfenidone versus TID pirfenidone

Timeframe: 14 Days

Part 3: AUC of TID deupirfenidone versus placebo

Timeframe: 6 Days

Trial details

NCT IDNCT07456800

SponsorPureTech

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-01

View on ClinicalTrials.gov More Pharmacokinetic Analysis trials