study to evaluate the food effect of tp-05 in healthy participants

Conditions: Healthy

Summary: 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.

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.

Eligibility criteria:
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