Study to Determine Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT… (NCT06717100) | Clinical Trial Compass
CompletedPhase 1
Study to Determine Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) and Nintedanib
Australia24 participantsStarted 2024-12-17
Plain-language 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 .
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
✕
What they're measuring
1
AUC of LYT-100 and nintedanib
Timeframe: 0-tlast: Day 1 to 20 for nintedanib; Day 8 to 30 for LYT-100
. 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.
✕. 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.