Study to Evaluate the Food Effect of TP-05 in Healthy Participants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TP-05, Fasted Group Single dose of TP-05 (lotilaner oral), fasted |
Drug: TP-05 (lotilaner oral), fasted group
TP-05 (lotilaner oral), fasted group
|
| Experimental: TP-05, High-Fat Group Single dose of TP-05 (lotilaner oral) following a high-fat meal |
Drug: TP-05 (lotilaner oral), high-fat group
TP-05 (lotilaner oral), high-fat group
|
| Experimental: TP-05, Low-Fat Group Single dose of TP-05 (lotilaner oral) following a low-fat meal |
Drug: TP-05 (lotilaner oral), low-fat group
TP-05 (lotilaner oral), low-fat group
|
Outcome Measures
Primary Outcome Measures
- 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 [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 [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 [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.
- Exposure and PK of lotilaner 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 Tlag.
Secondary Outcome Measures
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr. Vince Clinical Research | Overland Park | Kansas | United States | 66212 |
Sponsors and Collaborators
- Tarsus Pharmaceuticals, Inc.
Investigators
- Study Director: Jose Trevejo, MD, PhD, Tarsus Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TRS-017