Pharmacokinetic AnalysisPhase 1NCT07456800
PK of Deupirfenidone Versus Pirfenidone in Older Healthy Subjects
A Phase 1 study testing Deupirfenidone and Pirfenidone (PFD) in people with Pharmacokinetic Analysis, run by PureTech at 3 sites in United States.
Trial summary
A three-part, randomized, double-blind study in healthy older adults to identify a dose of deupirfenidone for further clinical study. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic Analysis
- What is being tested?
- Deupirfenidone and Pirfenidone (PFD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Jul 2021to 20 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hassman Research
Berlin, New Jersey, 08009
Accel Research Sites
Lake Mary, Florida, 32746
Collaborative Neuroscience Network, LLC.
Long Beach, California, 90806
About this study
Official title: A Phase 1, Double-Blind, Randomized, Crossover Study in Older Healthy Subjects to Compare the Safety, Tolerability, and Pharmacokinetics of Lyt-100 (Deupirfenidone) to Pirfenidone
A three-part, randomized, double-blind study in healthy older adults to identify a dose of deupirfenidone for further clinical study.
Read the detailed description
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.
- Conditions
- Pharmacokinetic Analysis
- Being tested
- Deupirfenidone, Pirfenidone (PFD), Placebo
- Keywords
- deupirfenidone, pirfenidone, PK, pharmacokinetics, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeupirfenidoneDrug
Also called LYT-100
Swedish orange capsule
Pirfenidone (PFD)Drug
Swedish orange capsule
PlaceboDrug
Swedish orange capsule
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Active | Experimental | deupirfenidone 850 mg BID Receives: Drug: Deupirfenidone |
| Part 1 Active Comparator | Active comparator | pirfenidone 801 mg TID Receives: Drug: Pirfenidone (PFD) |
| Part 2 Active | Experimental | deupirfenidone 550 mg TID Receives: Drug: Deupirfenidone |
| Part 2 Active Comparator | Active comparator | pirfenidone 801 mg TID Receives: Drug: Pirfenidone (PFD) |
| Part 3 Active | Experimental | deupirfenidone 550/824 mg TID Receives: Drug: Deupirfenidone |
| Part 3 Placebo | Placebo comparator | placebo TID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 days
Part 3: Cmax of TID deupirfenidone versus placebo
To evaluate the Cmax of two doses of deupirfenidone.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 Days
Part 3: AUC of TID deupirfenidone versus placebo
To evaluate the AUC of two doses of deupirfenidone.
Measured: 6 Days
Part 3: PK profile of TID deupirfenidone versus placebo
To evaluate the Tmax of two doses of deupirfenidone.
Measured: 6 Days
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start12 Jul 2021
- Primary completion1 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetic AnalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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 pharmacokinetics 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 pharmacokinetics 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 pharmacokinetics of two doses of deupirfenidone.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- PureTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven H Reynolds, DO, Principal investigator, Collaborative Neuroscience Network, LLC.Michael A Hassman, DO, Principal investigator, Hassman ResearchBruce G Rankin, DO, Principal investigator, Accel Research Sites
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456800
- Sponsor's protocol ID
- LYT-100-2021-103
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This was a pharmacokinetic study with no health-based outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Randomized, Crossover Study in Older Healthy Subjects to Compare the Safety, Tolerability, and Pharmacokinetics of Lyt-100 (Deupirfenidone) to Pirfenidone
- ClinicalTrials.gov ID
- NCT07456800
- Acronym / sponsor ID
- LYT-100-2021-103
- Conditions
- Pharmacokinetic Analysis
- Keywords
- deupirfenidone, pirfenidone, PK, pharmacokinetics, elderly
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- PureTechIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A three-part, randomized, double-blind study in healthy older adults to identify a dose of deupirfenidone for further clinical study.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- 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 pharmacokinetics 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 pharmacokinetics 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 pharmacokinetics of two doses of deupirfenidone.
| Arm | Type | Receives |
|---|---|---|
| Part 1 Active | Experimental | Drug: Deupirfenidonedeupirfenidone 850 mg BID |
| Part 1 Active Comparator | Active comparator | Drug: Pirfenidone (PFD)pirfenidone 801 mg TID |
| Part 2 Active | Experimental | Drug: Deupirfenidonedeupirfenidone 550 mg TID |
| Part 2 Active Comparator | Active comparator | Drug: Pirfenidone (PFD)pirfenidone 801 mg TID |
| Part 3 Active | Experimental | Drug: Deupirfenidonedeupirfenidone 550/824 mg TID |
| Part 3 Placebo | Placebo comparator | Drug: Placeboplacebo TID |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeupirfenidoneAlso: LYT-100Swedish orange capsule | Drug | Part 1 Active, Part 2 Active, Part 3 Active |
| Pirfenidone (PFD)Swedish orange capsule | Drug | Part 1 Active Comparator, Part 2 Active Comparator |
| PlaceboSwedish orange capsule | Drug | Part 3 Placebo |
Primary outcome
Part 1: Cmax of BID deupirfenidone versus TID pirfenidone
Time frame: 14 days
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.
Part 2: Cmax of TID deupirfenidone versus TID pirfenidone
Time frame: 14 days
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.
Part 3: Cmax of TID deupirfenidone versus placebo
Time frame: 6 days
To evaluate the Cmax of two doses of deupirfenidone.
Part 1: AUC of BID deupirfenidone versus TID pirfenidone
Time frame: 14 Days
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.
Part 1: Tmax of BID deupirfenidone versus TID pirfenidone
Time frame: 14 Days
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.
Part 2: AUC of TID deupirfenidone versus TID pirfenidone
Time frame: 14 Days
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.
Part 2: Tmax of TID deupirfenidone versus TID pirfenidone
Time frame: 14 Days
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.
Part 3: AUC of TID deupirfenidone versus placebo
Time frame: 6 Days
To evaluate the AUC of two doses of deupirfenidone.
Part 3: PK profile of TID deupirfenidone versus placebo
Time frame: 6 Days
To evaluate the Tmax of two doses of deupirfenidone.
6 secondary outcomes
Part 1: The effect of food on the Cmax of BID deupirfenidone versus TID pirfenidone
Time frame: 1 day
Part 2: The effect of food on the Cmax of TID deupirfenidone versus TID pirfenidone
Time frame: 1 day
Part 1: The effect of food on the AUC of BID deupirfenidone versus TID pirfenidone
Time frame: 6 Days
Part 1: The effect of food on the Tmax of BID deupirfenidone versus TID pirfenidone
Time frame: 1 Day
Part 2: The effect of food on the AUC of TID deupirfenidone versus TID pirfenidone
Time frame: 1 Day
Part 2: The effect of food on the Tmax of TID deupirfenidone versus TID pirfenidone
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No. This was a pharmacokinetic study with no health-based outcomes.
Related trials for Pharmacokinetic Analysis
Active, not recruitingPhase 2
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer
Breast Neoplasms
Not yet recruitingPhase 4
Oral Antibiotic Pharmacokinetics in Young Infants
Linezolid Pharmacokinetics in Young Infants, Pharmacokinetic Analysis
Not yet recruitingObservational study
A Predictive Model for Postoperative Analgesic Requirements After Abdominal Surgery
Postoperative Pain, Postoperative Analgesia
Not yet recruiting
Prognostic Biomarkers for Patients With Human Papillomavirus (HPV) Positive Oropharyngeal Squamous Cell Carcinoma
Oropharyngeal Squamous Cell Carcinoma (OPSCC), HPV
Not yet recruitingPhase 1
26DT052; Scaling Busulfan Dose to Body Surface Area in Children
Busulfan Pharmacokinetic Analysis, Busulfan Dosing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven H Reynolds, DO principal investigator
Collaborative Neuroscience Network, LLC.
Michael A Hassman, DO principal investigator
Hassman Research
Bruce G Rankin, DO principal investigator
Accel Research Sites
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deupirfenidone and Pirfenidone (PFD) in people with Pharmacokinetic Analysis, run by PureTech at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Cmax of BID deupirfenidone versus TID pirfenidone (time frame: 14 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.