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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: TP-05 (lotilaner oral), fasted group
* Drug: TP-05 (lotilaner oral), high-fat group
* Drug: TP-05 (lotilaner oral), low-fat group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TP-05, Fasted Group<br>Single dose of TP-05 (lotilaner oral), fasted | Drug: TP-05 (lotilaner oral), fasted group<br>* TP-05 (lotilaner oral), fasted group<br>* Other names: TP-05, fasted;|
| Experimental: TP-05, High-Fat Group<br>Single dose of TP-05 (lotilaner oral) following a high-fat meal | Drug: TP-05 (lotilaner oral), high-fat group<br>* TP-05 (lotilaner oral), high-fat group<br>* Other names: TP-05, high-fat meal;|
| Experimental: TP-05, Low-Fat Group<br>Single dose of TP-05 (lotilaner oral) following a low-fat meal | Drug: TP-05 (lotilaner oral), low-fat group<br>* TP-05 (lotilaner oral), low-fat group<br>* Other names: TP-05, low-fat meal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of TP-05 in whole blood | PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes concentration level. | Up to Day 60 | 
| Exposure and PK of lotilaner in whole blood (AUC0-96hours) | PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes AUC0-96hours. | Up to Day 5 | 
| Exposure and PK of lotilaner in whole blood (Cmax) | PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Cmax. | Up to Day 60 | 
| Exposure and PK of lotilaner in whole blood (Tmax) | PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Tmax. | Up to Day 60 | 
| Exposure and PK of lotilaner in whole blood (Tlag) | PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Tlag. | Up to Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events (TEAEs) | Evaluate the safety of TP-05 through the incidence rate of TEAEs | Up to Day 120 | 
| Clinically significant changes from Baseline chemistry laboratory tests | Evaluate the safety of TP-05 through clinically significant changes from Baseline chemistry laboratory tests | Up to Day 60 | 
| Clinically significant changes from Baseline physical examination | Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations | Up to Day 60 | 
| Clinically significant changes from Baseline vital signs | Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs | Up to Day 60 | 
| Clinically significant changes from Baseline electrocardiograms (ECGs) | Evaluate the safety of TP-05 through clinically significant changes from Baseline ECGs | Up to Day 60 |