Study to Evaluate the Food Effect of TP-05 in Healthy Participants

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.

Inclusion Criteria:Participants who are overtly healthy as determined by medical evaluation including medical history and physical examinationParticipants who are non- or ex-smokersNo 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 InvestigatorBMI 18.5-29.9 kg/m2 (inclusive) and weighs at least 50.0 kg at ScreeningAbility to comply with contraceptive requirementsExclusion 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 administrationHistory of significant hypersensitivity to lotilaner or any related productsHistory of significant gastrointestinal, metabolic, liver, or kidney disease, or surgery that may affect drug bioavailabilityHistory of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic diseaseHistory of malignancy (or active malignancy), with the exception of treated basal cell or squamous cell carcinomaPositive 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 -1Use 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 studyTreatment 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 studyHistory of live attenuated vaccine within 4 weeks prior to study drug administration or requirement to receive these vaccinations through Day 60 of the studyPlasma donation within 7 days prior to Screening through Day 60 of the studyBlood donation or significant blood loss approximately 500 mL within 56 days prior to Screening through Day 60 of the study