Study to Determine Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) and Nintedanib

NCT06717100 | Completed Phase 1 FDA Drug

• 1 other identifier: LYT-100-2024-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Drug Interactions

Keywords

LYT-100; nintedanib; deupirfenidone; drug interaction; interaction; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (5)

• 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.

  0-tlast: Day 1 to 20 for nintedanib; Day 8 to 30 for LYT-100

• AUC of LYT-100 and nintedanib

  0-12 hour

• AUC of LYT-100

  0-6 hour

• Tmax of LYT-100 and nintedanib

  0-12 hour

• Cmax of LYT-100 and nintedanib

  0-12 hour

Secondary Outcomes (12)

• Adverse Events

  Screening through Follow-up Visit on Day 60

• Number of subjects with abnormal vital signs (blood pressure)

  Screening through Follow-up Visit on Day 60

• Number of subjects with abnormal vital signs (heart rate)

  Screening through Follow-up Visit on Day 60

• Number of subjects with abnormal vital signs (respiration rate)

  Screening through Follow-up Visit on Day 60

• Number of subjects with abnormal vital signs (body temperature)

  Screening through Follow-up Visit on Day 60

Study Arms (1)

DDI Cohort

EXPERIMENTAL

All participants will receive the same interventions at the same schedule

Drug: Nintedanib 150 MG [Ofev]

Interventions

Nintedanib 150 MG [Ofev] DRUG

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.

Also known as: Deupirfenidone (LYT-100) 275 MG

DDI Cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Novotech (Australia) Pty Limited: collaborator
• PureTech: lead

Study Sites (1)

Nucleus Network Pty Ltd (Commercial Rd and St Kilda Rd) - VIC

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis

Interventions

nintedanib; pirfenidone

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 4, 2024
• Study Start: December 17, 2024
• Primary Completion: February 17, 2025
• Study Completion: March 17, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)