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

NCT05720364 | Completed Phase 1 FDA Drug

• 1 other identifier: TRS-017
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Incidence of treatment emergent adverse events (TEAEs)

  Up to Day 120

• Clinically significant changes from Baseline chemistry laboratory tests

  Up to Day 60

• Clinically significant changes from Baseline physical examination

  Up to Day 60

• Clinically significant changes from Baseline vital signs

  Up to Day 60

• Clinically significant changes from Baseline electrocardiograms (ECGs)

  Up to Day 60

Study Arms (3)

TP-05, Fasted Group

EXPERIMENTAL

Single dose of TP-05 (lotilaner oral), fasted

Drug: TP-05 (lotilaner oral), fasted group

TP-05, High-Fat Group

EXPERIMENTAL

Single dose of TP-05 (lotilaner oral) following a high-fat meal

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

TP-05, Low-Fat Group

EXPERIMENTAL

Single dose of TP-05 (lotilaner oral) following a low-fat meal

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

Interventions

TP-05 (lotilaner oral), fasted group DRUG

TP-05 (lotilaner oral), fasted group

Also known as: TP-05, fasted

TP-05, Fasted Group

TP-05 (lotilaner oral), high-fat group DRUG

TP-05 (lotilaner oral), high-fat group

Also known as: TP-05, high-fat meal

TP-05, High-Fat Group

TP-05 (lotilaner oral), low-fat group DRUG

TP-05 (lotilaner oral), low-fat group

Also known as: TP-05, low-fat meal

TP-05, Low-Fat Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tarsus Pharmaceuticals, Inc.: lead

Study Sites (1)

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Interventions

lotilaner

Study Officials

• Jose Trevejo, MD, PhD

  Tarsus Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: January 19, 2023
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

US (1)