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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: TP-05 (lotilaner oral), fasted group; Drug: TP-05 (lotilaner oral), high-fat group; Drug: TP-05 (lotilaner oral), low-fat group

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Dr. Vince Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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; Other Names: TP-05, fasted
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; Other Names: TP-05, high-fat meal
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; Other Names: TP-05, low-fat meal

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tarsus Pharmaceuticals, Inc.
• Investigators: Study Director: Jose Trevejo, MD, PhD, Tarsus Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TRS-017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No