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New drug formula tested for safety in seniors

NCT ID NCT07456800

Knowledge-focused Sponsor: PureTech Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called Lyt-100 (deupirfenidone) in 116 healthy adults aged 60-80 to see how safe it is and how the body processes it compared to the existing drug pirfenidone. The goal was to find the best dose for future studies, not to treat any disease. Participants received different doses of Lyt-100, pirfenidone, or a placebo in a blinded, crossover design.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

116 people

The number who actually took part.

Started

Jul 2021

Finished

Jan 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pharmacokinetic analysis

Contacts and locations

Locations

  • Accel Research Sites

    Lake Mary, Florida, 32746, United States

  • Collaborative Neuroscience Network, LLC.

    Long Beach, California, 90806, United States

  • Hassman Research

    Berlin, New Jersey, 08009, United States

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