Study to Evaluate the Food Effect of TP-05 in Healthy Participants
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About
A Phase 1, Open-Label, Randomized, Single-Dose, Parallel-Group Study to Evaluate the Food Effect on the Pharmacokinetics of TP-05 under Fed and Fasted Conditions in Healthy Participants.
Full description
This is a Phase 1, open-label, randomized, single-dose, parallel-group study to evaluate the food effect on the pharmacokinetics of TP-05 under fed and fasted conditions in healthy participants.
The study will consist of a screening period of up to 28 days. Participants who are eligible for the study will check into the clinical research site on Day -1. All participants will undergo an overnight fast of at least 10.5 hours prior to dosing. On Day -1 participants will be randomized to receive one of three treatment regimens on Day 1: single dose of TP-05, fasted; single dose of TP-05 following a high-fat breakfast; or single dose of TP-05 following a low-fat breakfast.
Participants will be resident at the clinical research site from Day -1 until completion of assessments at 96 hours post-dose (Day 5) and return on Day 60 for a follow-up visit. Participants will complete a telephone safety follow-up visit at Day 120.
Safety will be assessed by adverse events, vital signs, performing physical examinations, electrocardiograms, and evaluating clinical laboratory results.
Enrollment
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Inclusion criteria
- Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination
- Participants who are non- or ex-smokers
- No clinically significant disease captuired in medical history or evidence of clinically significant findings on the physical examination and/or ECG at Screening and Day -1, as determined by the Investigator
- BMI 18.5-29.9 kg/m2 (inclusive) and weighs at least 50.0 kg at Screening
- Ability to comply with contraceptive requirements
Exclusion criteria
- Female who is breast-feeding or pregnancy according to the serum pregnancy test at Screening and urine pregnancy test at Day -1 prior to study drug administration
- History of significant hypersensitivity to lotilaner or any related products
- History of significant gastrointestinal, metabolic, liver, or kidney disease, or surgery that may affect drug bioavailability
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
- History of malignancy (or active malignancy), with the exception of treated basal cell or squamous cell carcinoma
- Positive test results for HIV-1/HIV-2 antigen/antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (HCVAb)
- Positive result for SARS-CoV-2 testing at Day -1
- Use of any non-prescription or prescription drugs in the 7 days or 5 half-lives (whichever is longer) prior to study drug administration and through the treatment period of the study
- Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to Screening and through Day 60 of the study
- History of live attenuated vaccine within 4 weeks prior to study drug administration or requirement to receive these vaccinations through Day 60 of the study
- Plasma donation within 7 days prior to Screening through Day 60 of the study
- Blood donation or significant blood loss approximately 500 mL within 56 days prior to Screening through Day 60 of the study
Trial design
Primary purpose
Allocation
Interventional model
Masking
42 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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