Lyme Disease
Conditions
Keywords
Lyme Disease, Lyme Borreliosis, Lyme, Borrelia, Preventative Therapeutic, Prophylaxis, Healthy Volunteers, Randomized Controlled Trial, Gram-Negative Bacterial Infections, Bacterial Infections, Bacterial Infections and Mycoses, Infections, Borrelia Infections, Spirochaetales Infections, Tick-Borne Diseases, Vector Borne Diseases
Brief summary
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.
Detailed description
This is a randomized, double-blind, placebo-controlled study conducted in healthy adult participants prior to anticipated exposure to Lyme Borreliosis. Participants will be randomized to receive either TP05 or placebo according to a predefined dosing schedule. Safety will be evaluated through adverse event monitoring, clinical laboratory assessments, vital signs, and physical examinations. The study will consist of a screening period, a treatment period (up to 24 weeks) and a safety follow up period. Participants will be randomized to receive one of two treatment regimens of TP-05 or placebo. Participants will be followed up for approximately 15 months and evaluated further for tick bites or symptoms of Lyme borreliosis.
Interventions
DRUGTP-05 (lotilaner) Low Dose
TP05 administered orally at the protocol-defined preventative dose.
DRUGTP-05 (lotilaner) High Dose
TP05 administered orally at the protocol-defined preventative dose.
DRUGPlacebo
Matching placebo administered orally according to the same dosing schedule as TP05.
Sponsors
Tarsus Pharmaceuticals, Inc.
PPD Development, LP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Overtly healthy adult participants aged 18 to 70 years * Able to provide written informed consent * Willing and able to comply with study procedures * At high risk of exposure to ticks * Contraceptive use by men and women consistent with local regulations
Exclusion criteria
* Prior exposure to TP05 or any isooxazoline in the last 12 months * Known hypersensitivity to TP05 or related compounds * Clinically significant medical conditions that may interfere with study participation * Use of investigational products within 30 days prior to screening. * Received previous vaccination against Lyme borreliosis, including investigational vaccines intended to prevent Lyme borreliosis * Receiving long-term antibiotic therapy * Received active or passive immunization within 4 weeks prior to Day * Pregnant or breastfeeding individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of Treatment Emergent Adverse Events From Baseline | From day 1 through the end of study follow-up, an average of 15 months. | Safety and tolerability will be evaluated by incidence rate of treatment emergent adverse events from baseline. |
| Clinically Significant Changes From Baseline Chemistry Laboratory Tests | From day 1 through the end of study follow up, an average of 15 months. | Number of participants with clinically significant changes in clinical laboratory tests |
| Clinically Significant Changes From Baseline Hematology Laboratory Tests | From day 1 through the end of study follow up, an average of 15 months. | Number of participants with clinically significant changes in clinical laboratory tests. |
| Clinically Significant Changes From Baseline Vital Signs | From day 1 through the end of study follow up, an average of 15 months. | Number of participants with clinically significant changes in vital signs. |
| Clinically Significant Changes From Baseline Electrocardiograms (ECGs) | From day 1 through the end of study follow up, an average of 15 months. | Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in mean ventricular rate \[beats/min\]. |
| Clinically Significant Changes From Baseline Electrocardiograms (ECGs) Measures | From day 1 through the end of study follow up, an average of 15 months. | Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in pulse rate \[msec\]. |
| Clinically Significant Changes From Baseline QTC Interval | From day 1 through the end of study follow up, an average of 15 months. | Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QTC interval |
| Clinically Significant Changes From Baseline QRS Interval | From day 1 through the end of study follow up, an average of 15 months. | Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QRS interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Lotilaner in Whole Blood | From dose through study completion, an average of 15 months. | Concentration of lotilaner in whole blood at specified timepoints measured using validated bioanalytical assays. |
| Terminal Elimination Half Life (t½) of Lotilaner | At protocol specified timepoints through end study treatment phase, an average of 28 weeks. | Terminal elimination half life (t½) of lotilaner. |
| Area Under the Concentration Time Curve (AUC) of Lotilaner | At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months. | Area under the concentration time curve (AUC) of lotilaner. |
| Maximum Observed Concentration (Cmax) of Lotilaner | At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months. | Maximum observed concentration (Cmax) of lotilaner. |
| Time to Maximum Observed Concentration (Tmax) of Lotilaner | At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months. | Time to maximum observed concentration (Tmax) of lotilaner. |
Countries
United States
Outcome results
None listed