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

NCT05720364 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-06-28

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Tarsus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jose Trevejo, MD, PhD · Tarsus Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-19
Primary Completion
2023-05-30
Completion
2023-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05720364 on ClinicalTrials.gov