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Antiparasitic Agent

TP-05, Fasted Group for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Tarsus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 120
Awards & highlights

Study Summary

This trial tests how food affects a drug in healthy people, giving the drug either with food or on an empty stomach.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 120
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 120 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Concentration of TP-05 in whole blood
Exposure and PK of lotilaner in whole blood (AUC0-96hours)
Exposure and PK of lotilaner in whole blood (Cmax)
+2 more
Secondary outcome measures
Clinically significant changes from Baseline chemistry laboratory tests
Clinically significant changes from Baseline electrocardiograms (ECGs)
Clinically significant changes from Baseline physical examination
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: TP-05, Low-Fat GroupExperimental Treatment1 Intervention
Single dose of TP-05 (lotilaner oral) following a low-fat meal
Group II: TP-05, High-Fat GroupExperimental Treatment1 Intervention
Single dose of TP-05 (lotilaner oral) following a high-fat meal
Group III: TP-05, Fasted GroupExperimental Treatment1 Intervention
Single dose of TP-05 (lotilaner oral), fasted
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TP-05 (lotilaner oral), fasted group
2023
Completed Phase 1
~50
TP-05 (lotilaner oral), high-fat group
2023
Completed Phase 1
~50
TP-05 (lotilaner oral), low-fat group
2023
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Tarsus Pharmaceuticals, Inc.Lead Sponsor
9 Previous Clinical Trials
1,233 Total Patients Enrolled
Jose Trevejo, MD, PhDStudy DirectorTarsus Pharmaceuticals, Inc.
2 Previous Clinical Trials
177 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research encompass persons over fifty years of age?

"The age range for this clinical trial is 18 - 59 years, so any adult who meets that requirement can apply."

Answered by AI

Could you elucidate the potential health hazards of TP-05, Fasted Group?

"Our experts at Power assessed TP-05, Fasted Group to be relatively safe with a score of 1. This is due to the fact that this clinical trial has only conducted one phase of testing and has limited evidence regarding safety or efficacy."

Answered by AI

Is the research team currently seeking participants for this trial?

"The information on clinicaltrials.gov affirms that this medical experiment is currently recruiting participants, having been first posted to the website on January 19th 2023 and most recently updated February 8th 2023."

Answered by AI

What is the upper limit of participants in this exploration?

"Absolutely, according to the clinicaltrials.gov website this research trial is currently recruiting volunteers. This initiative was first introduced on January 19th 2023 and most recently updated on February 8th 2023. A total of 36 individuals are needed for one medical facility's participation in the study."

Answered by AI

What aims does this clinical experiment hope to accomplish?

"The primary end-point of this experiment, to be observed until Day 60, is the exposure and pharmacokinetics (PK) of lotilaner in whole blood. Secondary objectives include evaluating safety through clinically relevant changes from baseline chemistry laboratory tests, physical examinations, and vital signs."

Answered by AI

What criteria must potential participants fulfill in order to qualify for this experiment?

"This trial requires 36 volunteers who are between 18 and 59 years old, have no underlying medical conditions, do not smoke or are ex-smokers, weigh a minimum of 50 kgs with BMI scores from 18.5 to 29.9 (inclusive), as well as adhere to contraceptive regulations in order to participate."

Answered by AI
~19 spots leftby Apr 2025