Healthy
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGTP-05 (lotilaner oral), fasted group
TP-05 (lotilaner oral), fasted group
DRUGTP-05 (lotilaner oral), high-fat group
TP-05 (lotilaner oral), high-fat group
DRUGTP-05 (lotilaner oral), low-fat group
TP-05 (lotilaner oral), low-fat group
Sponsors
Tarsus Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exposure and PK of lotilaner in whole blood (Tlag) | Up to Day 60 | 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. |
| Concentration of TP-05 in whole blood | Up to Day 60 | 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. |
| Exposure and PK of lotilaner in whole blood (AUC0-96hours) | Up to Day 5 | 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. |
| Exposure and PK of lotilaner in whole blood (Cmax) | Up to Day 60 | 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. |
| Exposure and PK of lotilaner in whole blood (Tmax) | Up to Day 60 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment emergent adverse events (TEAEs) | Up to Day 120 | Evaluate the safety of TP-05 through the incidence rate of TEAEs |
| Clinically significant changes from Baseline chemistry laboratory tests | Up to Day 60 | Evaluate the safety of TP-05 through clinically significant changes from Baseline chemistry laboratory tests |
| Clinically significant changes from Baseline physical examination | Up to Day 60 | Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations |
| Clinically significant changes from Baseline vital signs | Up to Day 60 | Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs |
| Clinically significant changes from Baseline electrocardiograms (ECGs) | Up to Day 60 | Evaluate the safety of TP-05 through clinically significant changes from Baseline ECGs |
Countries
United States
Outcome results
None listed