Clinical trial NCT05720364: Study to Evaluate the Food Effect of TP-05 in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Tarsus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Concentration of TP-05 in whole blood
timeFrame: Up to Day 60
measure: Exposure and PK of lotilaner in whole blood (AUC0-96hours)
timeFrame: Up to Day 5
measure: Exposure and PK of lotilaner in whole blood (Cmax)
timeFrame: Up to Day 60
measure: Exposure and PK of lotilaner in whole blood (Tmax)
timeFrame: Up to Day 60
measure: Exposure and PK of lotilaner in whole blood (Tlag)
timeFrame: Up to Day 60
Secondary outcomes:
measure: Incidence of treatment emergent adverse events (TEAEs)
timeFrame: Up to Day 120
measure: Clinically significant changes from Baseline chemistry laboratory tests
timeFrame: Up to Day 60
measure: Clinically significant changes from Baseline physical examination
timeFrame: Up to Day 60
measure: Clinically significant changes from Baseline vital signs
timeFrame: Up to Day 60
measure: Clinically significant changes from Baseline electrocardiograms (ECGs)
timeFrame: Up to Day 60
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Dr. Vince Clinical Research
state: Kansas
Study officials:
affiliation: Tarsus Pharmaceuticals, Inc.
name: Jose Trevejo, MD, PhD
role: STUDY_DIRECTOR
References: