NCT05720364

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Tarsus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	TP-05 (lotilaner oral), fasted group	TP-05 (lotilaner oral), fasted group
DRUG	TP-05 (lotilaner oral), high-fat group	TP-05 (lotilaner oral), high-fat group
DRUG	TP-05 (lotilaner oral), low-fat group	TP-05 (lotilaner oral), low-fat group

Timeline

• Start date: 2023-01-19
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2023-02-09
• Last updated: 2023-06-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study