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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05720364
• Other study ID #: TRS-017
• Status: Completed
• Phase: Phase 1
• Start date: January 19, 2023
• Est. completion date: May 30, 2023

Study information

• Verified date: June 2023
• Source: Tarsus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• TP-05 (lotilaner oral), fasted group
TP-05 (lotilaner oral), fasted group
• TP-05 (lotilaner oral), high-fat group
TP-05 (lotilaner oral), high-fat group
• TP-05 (lotilaner oral), low-fat group
TP-05 (lotilaner oral), low-fat group

Locations

Country	Name	City	State
United States	Dr. Vince Clinical Research	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Tarsus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Incidence of treatment emergent adverse events (TEAEs)	Evaluate the safety of TP-05 through the incidence rate of TEAEs	Up to Day 120
Secondary	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
Secondary	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
Secondary	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
Secondary	Clinically significant changes from Baseline electrocardiograms (ECGs)	Evaluate the safety of TP-05 through clinically significant changes from Baseline ECGs	Up to Day 60