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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
TP-05 (lotilaner oral), fasted group
TP-05 (lotilaner oral), high-fat group
TP-05 (lotilaner oral), low-fat group
Dr. Vince Clinical Research
Overland Park, Kansas, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 60
Incidence of treatment emergent adverse events (TEAEs)
Evaluate the safety of TP-05 through the incidence rate of TEAEs
Time frame: Up to Day 120
Clinically significant changes from Baseline chemistry laboratory tests
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Evaluate the safety of TP-05 through clinically significant changes from Baseline chemistry laboratory tests
Time frame: 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
Time frame: 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
Time frame: Up to Day 60
Clinically significant changes from Baseline electrocardiograms (ECGs)
Evaluate the safety of TP-05 through clinically significant changes from Baseline ECGs
Time frame: Up to Day 60