A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure
ConditionLyme Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTarsus Pharmaceuticals, Inc.
About this trial
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
TP-05 (lotilaner) Low Dose
DrugTP05 administered orally at the protocol-defined preventative dose.
TP-05 (lotilaner) High Dose
DrugTP05 administered orally at the protocol-defined preventative dose.
Placebo
DrugMatching placebo administered orally according to the same dosing schedule as TP05.
Treatment groups
700 Participants
are divided into 3 treatment groupsGroup A: TP-05 (lotilaner) High DoseActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: TP-05 (lotilaner) Low DoseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The Incidence of Treatment Emergent Adverse Events From Baseline
Safety and tolerability will be evaluated by incidence rate of treatment emergent adverse events from baseline.
Time frame
From day 1 through the end of study follow-up, an average of 15 months.2
Clinically Significant Changes From Baseline Chemistry Laboratory Tests
Number of participants with clinically significant changes in clinical laboratory tests
Time frame
From day 1 through the end of study follow up, an average of 15 months.3
Clinically Significant Changes From Baseline Hematology Laboratory Tests
Number of participants with clinically significant changes in clinical laboratory tests.
Time frame
From day 1 through the end of study follow up, an average of 15 months.4
Clinically Significant Changes From Baseline Vital Signs
Number of participants with clinically significant changes in vital signs.
Time frame
From day 1 through the end of study follow up, an average of 15 months.Secondary outcomes
1
Concentration of Lotilaner in Whole Blood
Concentration of lotilaner in whole blood at specified timepoints measured using validated bioanalytical assays.
Time frame
From dose through study completion, an average of 15 months.2
Terminal Elimination Half Life (t½) of Lotilaner
Terminal elimination half life (t½) of lotilaner.
Time frame
At protocol specified timepoints through end study treatment phase, an average of 28 weeks.3
Area Under the Concentration Time Curve (AUC) of Lotilaner
Area under the concentration time curve (AUC) of lotilaner.
Time frame
At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.4
Maximum Observed Concentration (Cmax) of Lotilaner
Maximum observed concentration (Cmax) of lotilaner.
Time frame
At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tarsus Pharmaceuticals, Inc.
Lead sponsor
PPD Development, LP
Collaborator
Source ClinicalTrials.gov