Drug InteractionsPhase 1NCT06717100
Study to Determine Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) and Nintedanib
A Phase 1 study testing Nintedanib 150 MG [Ofev] in people with Drug Interactions, run by PureTech at 1 site in Australia.
Trial summary
This is a trial of up to 60-day duration for safety, tolerability, and pharmacokinetics in healthy volunteers administered deupirfenidone (LYT-100) alone or in combination with nintedanib . Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interactions
- What is being tested?
- Nintedanib 150 MG [Ofev]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Dec 2024to 17 Mar 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provides written Ethics Committee approved informed consent prior to any study procedures.
- Male or female between 18 and 65 years old (inclusive) at the time of Screening.
- In good general health at Screening, free from clinically significant unstable and/or acute medical, surgical or psychiatric illness/es and a full physical examination, at the discretion of the Investigator.
- Clinical laboratory analytes at Screening and Day -1 (including hematology, biochemistry, coagulation, and urinalysis) within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI.
- Subjects have a body mass index (BMI) between ≥ 18.0 and ≤ 35.0 kg/m2 and weigh at least 50 kg at Screening.
- Vital signs (measured in sitting position after 5 minutes' rest) at Screening and at Day -1:
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- Systolic blood pressure ≥90 and ≤140 mmHg; and
- Diastolic blood pressure ≥40 and ≤ 90 mmHg; and
- Heart rate ≥40 and ≤100 beats per minute (bpm). Note: If vital signs are out of range, the Investigator may obtain one additional reading, so that up to 2 consecutive assessments are made within 1 hour and with the subject seated quietly during the 5 minutes preceding the assessment.
- Adequate venous access in the left or right arm to allow collection of multiple blood samples.
- No relevant dietary restrictions, and willing to consume the entirety of the standard meals provided.
- Willing to comply with all study procedures and requirements.
- Willing to abstain from direct whole body sun exposure from 2 days prior to dosing and until EOS/Follow-up Visit.
- Women of childbearing potential (WOCBP) must be non-pregnant and non-lactating, and must use acceptable, highly effective contraception or be abstinent from heterosexual intercourse if this is their usual sexual practice from Screening until study completion, including the follow-up period and an additional 90 days after the last dose of study drug. Effective forms of contraception are defined in Section 4.4.4 of the protocol. WOCBP must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Day -1 and be willing to have additional pregnancy tests as required throughout the study.
- Women not of childbearing potential must be post menopausal for ≥12 months (without an alternative medical cause) or be surgically sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). Post-menopausal status will be confirmed through testing of follicle stimulating hormone (FSH) levels ≥ 40 IU/L at Screening. Bilateral tubal ligation is acceptable (if completed successfully and done at least one year prior to Screening [verbal confirmation is permitted]), but condom use by male partner is required until study completion including the follow-up period.
- Male subjects must be surgically sterile (> 90 days since vasectomy with no viable sperm confirmed by laboratory documentation), abstinent if this is their usual sexual practice, or if engaged in sexual relations with a WOCBP, the subject and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method (See Section 4.4.4 of the protocol) from Screening until study completion, including the follow-up period and an additional 90 days after the last dose of study drug. Male subjects that have undergone a vasectomy must use a condom from Screening until study completion, including the follow-up period and an additional 90 days after the last dose of study drug.
- Males must not donate sperm and females must not donate ova or oocytes (i.e., human eggs) for at least 90 days after the last dose of study drug.
- Subjects with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle.
Who cannot join
- Pregnant or lactating at Screening or Day -1 or planning to become pregnant (self or partner) at any time during the study, including the specified follow-up period.
- History or presence of malignancy at Screening or Day -1, with the exception of adequately treated localised skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix.
- History of migraine, whether treated or untreated, within 3 years prior to Screening
- Clinically significant infection within 28 days of the start of dosing, or infections requiring parenteral antibiotics within the 6 months prior to Screening.
- Clinically significant surgical procedure within 3 months of Screening, at the discretion of the Investigator, or any planned significant surgical procedure prior to the EOS/Follow-up visit.
- Family history (biological relatives [i.e., parents, siblings]) of long or short QT syndrome, or Torsades de Pointes.
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- Currently suffering from clinically significant systemic allergic disease at Screening or Day -1 or has a history of significant drug allergies including a history of anaphylactic reaction; allergic reaction due to any drug which led to significant morbidity; prior allergic reaction to pirfenidone.
- Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to study drug administration; corticosteroids are permitted at the discretion of the Investigator). Topical agents are not exclusionary.
- History or presence at Screening or Day -1 of a condition associated with significant immunosuppression.
- Positive result of a RT-qPCR diagnostic test for SARS-CoV-2 at Screening or Day -1.
- Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening. Subjects who are positive for HCVAb will be tested for hepatitis C ribonucleic acid (HCV RNA) by polymerase chain reaction (PCR) and, if HCV RNA PCR is positive, will be excluded.
- Symptoms of dysphagia at Screening or Day -1 or known difficulty in swallowing capsules.
- History or presence of gastrointestinal (including a previous episode of pancreatitis), hepatic or renal disease, or any other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any condition at Screening or Day -1 (e.g., chronic diarrhoea, inflammatory bowel disease or prior surgery of the gastrointestinal tract) that would interfere with drug absorption or any disease or condition that is likely to affect drug metabolism or excretion, at the discretion of the Investigator.
- History or presence at Screening or Day -1 of cardiac arrhythmia or congenital long QT syndrome.
- QT interval corrected using Fridericia's formula (QTcF) > 450 msec (male) or 470 msec (female) demonstrated by two ECGs 30 to 60 minutes apart at Screening or Day -1 visits. The average of the 2 QTcF intervals should be used to determine the subject's eligibility.
- Use of smoked tobacco or nicotine containing products in the previous 3 months prior to dosing or use of other tobacco or nicotine containing products in the previous 2 weeks prior to dosing, or a positive urine cotinine test at Screening or Day -1.
- Lack of willingness to abstain from the consumption of tobacco or nicotine-containing products throughout the duration of the study and until the EOS/Follow-up visit.
- Lack of willingness to abstain from the use of alcohol throughout the study (Treatment through EOS/Follow-up visit).
- Positive toxicology screening panel (urine test, including qualitative identification of barbiturates, tetrahydrocannabinol [THC], amphetamines, benzodiazepines, opiates and cocaine) or alcohol breath test at Screening or Day -1, at any time during the Study. One repeat urine toxicology screen may be conducted, within 48 h of the first, if the first is considered by the Investigator to be invalid.
- History of substance abuse or dependency or history of recreational intravenous (IV) drug use, over the last 2 years.
- Use of any prescription drugs, over the counter (OTC) medication, nonsteroidal anti-inflammatory agents (NSAIDs), herbal remedies, supplements or vitamins within the 14 days prior to dosing or throughout the duration of the study, without prior approval of the Investigator and written approval of the Medical Monitor.
- Paracetamol/acetaminophen may be utilised, provided that the dose of paracetamol does not exceed 2 g in any 24 h period.
- Use of any of the any drugs listed in Section 4.4.1 within 28 days or 5 half-lives of that drug, whichever is longer, prior to study drug administration.
- Vaccination with a live vaccine within the 4 weeks prior to Screening or that is planned prior to the EOS visit, and any non-live vaccination within the 2 weeks prior to Screening or that is planned within 2 weeks of dosing (including those for COVID-19)
- Exposure to any significantly immune suppressing drug within the 3 months prior to Screening or 5 half lives, whichever is longer.
- Use of any investigational drug or device within 3 months prior to Screening.
- Consumption of soy, grapefruit, grapefruit juice, Seville oranges, Seville orange juice, or any foods containing these ingredients, within 7 days prior to dosing until 24 hours after the final dose of study drug or unwilling to abstain from these throughout the duration of the study, until the EOS visit.
- Clinically significant blood loss, blood or blood product donation >250 mL within 28 days of Screening.
- Subject is unwilling to refrain from strenuous exercise which significantly exceeds the subject's usual level of physical activity from 48 h prior to admission to the clinical trial unit and until completion of the final onsite follow-up visit, where strenuous exercise is defined as a significant increase in the Subject's usual level of physical activity or lifting weights or running uphill.
- Any other reason that, in the opinion of the Investigator, might interfere with the evaluation required by the study.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Nucleus Network Pty Ltd (Commercial Rd and St Kilda Rd) - VIC
Melbourne, Victoria, 3004
About this study
Official title: A Phase 1 Study in Healthy Volunteers to Determine the Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) With Nintedanib
This is a trial of up to 60-day duration for safety, tolerability, and pharmacokinetics in healthy volunteers administered deupirfenidone (LYT-100) alone or in combination with nintedanib .
Read the detailed description
The purpose of this research is to investigate the effects of deupirfenidone (LYT-100) when co-administered with nintedanib to determine if there are any drug-drug interactions. In particular, the study will investigate the safety, tolerability and pharmacokinetics of LYT-100 co-administered with nintedanib. Eligible participants will be admitted to the Clinical Research Unit for 31 days, will be administered nintedanib and/or LYT-100 for 30 days, and will provide blood samples and have assessments during this time. Participants will return for a safety follow-up visit 30 days after taking the last dose of study drug.
- Conditions
- Drug Interactions
- Being tested
- Nintedanib 150 MG [Ofev]
- Keywords
- LYT-100, nintedanib, deupirfenidone, drug interaction, interaction, Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis
- Medical subject headings
- Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintedanib 150 MG [Ofev]Drug
Also called Deupirfenidone (LYT-100) 275 MG
Nintedanib 150 MG will be administered every 12 hours from Days 1 to 20. LYT-100 will be titrated from 275 MG three times a day on Days 8 to 10, to 550 MG three times a day on Days 11 to 13, to 825 MG three times a day on Days 14 to 30.
| Study group | Role | What they receive |
|---|---|---|
| DDI Cohort | Experimental | All participants will receive the same interventions at the same schedule Receives: Drug: Nintedanib 150 MG [Ofev] |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of LYT-100 and Nintedanib
The area under the curve will be calculated from the first observed to last measurable plasma concentration. For nintedanib, dosing begins on Day 1 and ends on Day 20. For LYT-100, dosing begins on Day 8 and ends on Day 30.
Measured: Blood samples for PK analysis were collected on Days 7, 13, 20, and 30 to assess the steady-state plasma PK profiles of nintedanib and/or LYT-100
Tmax of LYT-100 and Nintedanib
The time to maximum concentration (Tmax) will be calculated from the first observed to last measurable plasma concentration. For nintedanib, dosing begins on Day 1 and ends on Day 20. For LYT-100, dosing begins on Day 8 and ends on Day 30.
Measured: Blood samples for PK analysis were collected on Days 7, 13, 20, and 30 to assess the steady-state plasma PK profiles of nintedanib and/or LYT-100
Cmax of LYT-100 and Nintedanib
The maximum observed plasma concentration (Cmax) will be calculated from the first observed to last measurable plasma concentration. For nintedanib, dosing begins on Day 1 and ends on Day 20. For LYT-100, dosing begins on Day 8 and ends on Day 30.
Measured: Blood samples for PK analysis were collected on Days 7, 13, 20, and 30 to assess the steady-state plasma PK profiles of nintedanib and/or LYT-100
Secondary outcomes (10)
Number of Subjects With Abnormal Vital Signs (Blood Pressure)
Systolic and Diastolic blood pressure measured in millimeters of mercury (mmHg) to determine if there is abnormal blood pressure
Measured: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Vital Signs (Heart Rate)
Heart rate is measured in beats per minute (bpm) to determine if there is an abnormal heart rate
Measured: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Vital Signs (Respiration Rate)
Respiration rate is measured in breaths per minute (bpm) to determine if the respiration rate is abnormal
Measured: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Vital Signs (Body Temperature)
Tympanic body temperature is measured in degrees Celsius to determine if the body temperature is abnormal
Measured: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Electrocardiograms
Number of participants with an abnormal ECG and/or that have a QTcF>450 ms
Measured: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Physical Examinations
A physical examination is performed to determine if any physical abnormalities are detected
Measured: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Laboratory Values (Hematology)
Hematology parameters to be tested are hemoglobin, hematocrit, erythrocytes, platelets, and leukocytes.
Measured: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Laboratory Values (Serum Chemistry)
Serum chemistry parameters to be tested are C-reactive protein, urea, creatinine, total and direct bilirubin, urate, albumin, globulin, alkaline phosphatase, creatine phosphokinase, troponin 1, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, glucose, sodium, potassium, calcium, chloride, phosphate, bicarbonate
Measured: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Laboratory Values (Coagulation)
Coagulation parameters to be tested are international normalized ratio, prothrombin time, activated partial thromboplastin time
Measured: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Laboratory Values (Urinalysis)
Urinalysis parameters to be tested are micro protein, nitrite, pH, trial specific gravity, ketone bodies, urobilinogen, blood, urine leukocyte esterase, appearance uri acm, micro glucose, bilirubin
Measured: Screening through Follow-up Visit on Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start17 Dec 2024
- Primary completion17 Feb 2025
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Drug InteractionsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- PureTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717100
- Sponsor's protocol ID
- LYT-100-2024-03
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2024
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study in Healthy Volunteers to Determine the Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) With Nintedanib
- ClinicalTrials.gov ID
- NCT06717100
- Acronym / sponsor ID
- LYT-100-2024-03
- Conditions
- Drug Interactions
- Keywords
- LYT-100, nintedanib, deupirfenidone, drug interaction, interaction, Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PureTechIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a trial of up to 60-day duration for safety, tolerability, and pharmacokinetics in healthy volunteers administered deupirfenidone (LYT-100) alone or in combination with nintedanib .
Detailed description
The purpose of this research is to investigate the effects of deupirfenidone (LYT-100) when co-administered with nintedanib to determine if there are any drug-drug interactions. In particular, the study will investigate the safety, tolerability and pharmacokinetics of LYT-100 co-administered with nintedanib. Eligible participants will be admitted to the Clinical Research Unit for 31 days, will be administered nintedanib and/or LYT-100 for 30 days, and will provide blood samples and have assessments during this time. Participants will return for a safety follow-up visit 30 days after taking the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DDI Cohort | Experimental | Drug: Nintedanib 150 MG [Ofev]All participants will receive the same interventions at the same schedule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Provides written Ethics Committee approved informed consent prior to any study procedures.
- Male or female between 18 and 65 years old (inclusive) at the time of Screening.
- In good general health at Screening, free from clinically significant unstable and/or acute medical, surgical or psychiatric illness/es and a full physical examination, at the discretion of the Investigator.
- Clinical laboratory analytes at Screening and Day -1 (including hematology, biochemistry, coagulation, and urinalysis) within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI.
- Subjects have a body mass index (BMI) between ≥ 18.0 and ≤ 35.0 kg/m2 and weigh at least 50 kg at Screening.
Key exclusion criteria (31 listed)
- Pregnant or lactating at Screening or Day -1 or planning to become pregnant (self or partner) at any time during the study, including the specified follow-up period.
- History or presence of malignancy at Screening or Day -1, with the exception of adequately treated localised skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix.
- History of migraine, whether treated or untreated, within 3 years prior to Screening
- Clinically significant infection within 28 days of the start of dosing, or infections requiring parenteral antibiotics within the 6 months prior to Screening.
- Clinically significant surgical procedure within 3 months of Screening, at the discretion of the Investigator, or any planned significant surgical procedure prior to the EOS/Follow-up visit.
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 |
|---|---|---|
| Nintedanib 150 MG [Ofev]Also: Deupirfenidone (LYT-100) 275 MGNintedanib 150 MG will be administered every 12 hours from Days 1 to 20. LYT-100 will be titrated from 275 MG three times a day on Days 8 to 10, to 550 MG three times a day on Days 11 to 13, to 825 MG three times a day on Days 14 to 30. | Drug | DDI Cohort |
Primary outcome
AUC of LYT-100 and Nintedanib
Time frame: Blood samples for PK analysis were collected on Days 7, 13, 20, and 30 to assess the steady-state plasma PK profiles of nintedanib and/or LYT-100
The area under the curve will be calculated from the first observed to last measurable plasma concentration. For nintedanib, dosing begins on Day 1 and ends on Day 20. For LYT-100, dosing begins on Day 8 and ends on Day 30.
Tmax of LYT-100 and Nintedanib
Time frame: Blood samples for PK analysis were collected on Days 7, 13, 20, and 30 to assess the steady-state plasma PK profiles of nintedanib and/or LYT-100
The time to maximum concentration (Tmax) will be calculated from the first observed to last measurable plasma concentration. For nintedanib, dosing begins on Day 1 and ends on Day 20. For LYT-100, dosing begins on Day 8 and ends on Day 30.
Cmax of LYT-100 and Nintedanib
Time frame: Blood samples for PK analysis were collected on Days 7, 13, 20, and 30 to assess the steady-state plasma PK profiles of nintedanib and/or LYT-100
The maximum observed plasma concentration (Cmax) will be calculated from the first observed to last measurable plasma concentration. For nintedanib, dosing begins on Day 1 and ends on Day 20. For LYT-100, dosing begins on Day 8 and ends on Day 30.
10 secondary outcomes
Number of Subjects With Abnormal Vital Signs (Blood Pressure)
Time frame: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Vital Signs (Heart Rate)
Time frame: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Vital Signs (Respiration Rate)
Time frame: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Vital Signs (Body Temperature)
Time frame: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Electrocardiograms
Time frame: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Physical Examinations
Time frame: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Laboratory Values (Hematology)
Time frame: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Laboratory Values (Serum Chemistry)
Time frame: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Laboratory Values (Coagulation)
Time frame: Screening through Follow-up Visit on Day 60
Number of Subjects With Abnormal Laboratory Values (Urinalysis)
Time frame: Screening through Follow-up Visit on Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nintedanib 150 MG [Ofev] in people with Drug Interactions, run by PureTech at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 31 exclusion criteria. 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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. 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?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
AUC of LYT-100 and Nintedanib (time frame: Blood samples for PK analysis were collected on Days 7, 13, 20, and 30 to assess the steady-state plasma PK profiles of nintedanib and/or LYT-100). The study lists 3 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 13 Aug 2026.