A Pharmacokinetic Study of TP-05 in Healthy Subjects

August 1, 2022 updated by: Tarsus Pharmaceuticals, Inc.

A Phase 1, Randomized, Double-Blind, Single- and Multiple-Ascending-Dose Study Evaluating the Safety, Tolerability, Food-Effect and Pharmacokinetics of TP-05 in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Single- and Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, Food-Effect and Pharmacokinetics of TP-05 in Healthy Subjects

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This Phase 1 study is a randomized, double-blind, single- and multiple-ascending dose trial to evaluate the safety, tolerability, food-effect, and pharmacokinetics of TP-05 in healthy subjects. Subjects will be enrolled in 5 sequential, ascending single dose cohorts and 3 multiple, ascending dose cohorts. Dose escalation will be approved by a safety monitoring committee before beginning the next cohort. The Safety Review Committee (SRC) will evaluate if any dose-limiting adverse events (AEs) through Day 15 (in Cohorts 1-5) or through Day 36 (in Cohorts 6-8) occurred in a cohort before proceeding to dosing in the next dose level. In addition, the SRC will review selected PK parameters after selected cohorts. Skin punch biopsies, and venous, capillary, and urine samples may be collected at various timepoints for pharmacokinetic analysis. Safety assessments include monitoring of adverse events, clinical laboratory testing, vital sign measurements, physical examinations, and ECGs. A blood sample may also be collected to evaluate tick mortality upon exposure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Altasciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form (ICF)
  2. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator

Exclusion Criteria:

  1. Female who is pregnant or lactating
  2. Presence or history of significant gastrointestinal, metabolic, liver or kidney disease, or surgery that may affect drug bioavailability (excluding appendectomy and cholecystectomy)
  3. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
  4. Have a history of a malignancy (or active malignancy), with the exception of treated basal cell or squamous cell carcinoma
  5. Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) within 14 days prior to or use of any over-the-counter drugs in the 7 days prior to the first study drug administration
  6. Positive urine alcohol test result and/or drugs of abuse at Screening or prior to the first drug administration (including cotinine, cannabinoids, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines)
  7. Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg) or Hepatitis C Antibody (HCVAb)
  8. Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to Screening
  9. Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening
  10. Plasma donation within 7 days prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TP-05 SAD
Single dose of TP-05 (lotilaner oral capsules) at 4 dose levels in ascending order
Drug: TP-05 (lotilaner oral capsules)
TP-05 (lotilaner oral capsules)
Experimental: Placebo SAD
Single dose of Placebo
Drug: Placebo
Placebo to match TP-05 (lotilaner oral capsules)
Experimental: TP-05 MAD
Four doses of TP-05 (lotilaner oral capsules) at 3 dose levels in ascending order
Drug: TP-05 (lotilaner oral capsules)
TP-05 (lotilaner oral capsules)
Experimental: Placebo MAD
Four doses of Placebo
Drug: Placebo
Placebo to match TP-05 (lotilaner oral capsules)
Experimental: TP-05 Fasted
Single dose of TP-05 (lotilaner oral capsules) in a fasted state
Drug: TP-05 (lotilaner oral capsules)
TP-05 (lotilaner oral capsules)
Experimental: Placebo Fasted
Single dose of placebo in a fasted state
Drug: Placebo
Placebo to match TP-05 (lotilaner oral capsules)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of treatment emergent adverse events (TEAEs)
Time Frame: up to 151 days
Evaluate the safety of TP-05 through the incidence rate of TEAEs
up to 151 days
Clinically significant changes from Baseline chemistry laboratory tests
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline chemistry laboratory tests
up to 151 days
Clinically significant changes from Baseline hematology laboratory tests
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline hematology laboratory tests
up to 151 days
Clinically significant changes from Baseline general appearance
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline general appearance
up to 151 days
Clinically significant changes from Baseline physical examination of head, ears, nose, and throat
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of head, ears, nose, and throat
up to 151 days
Clinically significant changes from Baseline physical examination of neck (thyroid)
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of neck (thyroid)
up to 151 days
Clinically significant changes from Baseline physical examination of respiratory system
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of respiratory system
up to 151 days
Clinically significant changes from Baseline physical examination of cardiovascular system
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of cardiovascular system
up to 151 days
Clinically significant changes from Baseline physical examination of gastrointestinal system
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of gastrointestinal system
up to 151 days
Clinically significant changes from Baseline physical examination of neurological system
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of neurological system
up to 151 days
Clinically significant changes from Baseline physical examination of musculoskeletal system (extremities)
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examination of musculoskeletal system (extremities)
up to 151 days
Clinically significant changes from Baseline physical examination of skin
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examination of skin
up to 151 days
Clinically significant changes from Baseline vital signs
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs (including temperature [degrees Celsius], pulse rate [beats per minute], respiration rate [breaths per minute], and changes in systolic and diastolic blood pressure [mmHg])
up to 151 days
Clinically significant changes from Baseline vital signs (temperature [degrees Celsius])
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including temperature [degrees Celsius]
up to 151 days
Clinically significant changes from Baseline vital signs (pulse rate [beats per minute])
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including pulse rate [beats per minute]
up to 151 days
Clinically significant changes from Baseline vital signs (respiration rate [breaths per minute])
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including respiration rate [breaths per minute]
up to 151 days
Clinically significant changes from Baseline vital signs (systolic and diastolic blood pressure [mmHg])
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including changes in systolic and diastolic blood pressure [mmHg])
up to 151 days
Clinically significant changes from Baseline electrocardiograms (ECGs)
Time Frame: up to 151 days
Evaluate the safety of TP-05 through clinically significant changes from Baseline ECGs (including changes in mean ventricular rate [beats/min], pulse rate [msec], QRS duration [msec], QT interval [msec], QTcF interval [msec])
up to 151 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exposure and PK of lotilaner in whole blood
Time Frame: up to 151 days
PK parameters for whole blood sampling methods following dose administration will be evaluated and include Cmax at various times
up to 151 days
Exposure and PK of lotilaner in whole blood
Time Frame: up to 151 days
PK parameters for whole blood sampling methods following dose administration will be evaluated and include Tmax at various times
up to 151 days
Exposure and PK of lotilaner in whole blood
Time Frame: up to 151 days
PK parameters for whole blood sampling methods following dose administration will be evaluated and include Tlag at various times
up to 151 days
Exposure and PK of lotilaner in whole blood
Time Frame: up to 151 days
PK parameters for whole blood sampling methods following dose administration will be evaluated and include AUC0-168 at various times
up to 151 days
Exposure and PK of lotilaner in whole blood
Time Frame: up to 151 days
PK parameters for whole blood sampling methods following dose administration will be evaluated and include AUC0-2880 at various times
up to 151 days
Exposure and PK of lotilaner in whole blood
Time Frame: up to 151 days
PK parameters for whole blood sampling methods following dose administration will be evaluated and include AUC0-t at various times
up to 151 days
Exposure and PK of lotilaner in whole blood
Time Frame: up to 151 days
PK parameters for whole blood sampling methods following dose administration will be evaluated and include AUC0-inf at various times
up to 151 days
Exposure and PK of lotilaner in whole blood
Time Frame: up to 151 days
PK parameters for whole blood sampling methods following dose administration will be evaluated and include CL/F at various times
up to 151 days
Exposure and PK of lotilaner in whole blood
Time Frame: up to 151 days
PK parameters for whole blood sampling methods following dose administration will be evaluated and include Vz/F at various times
up to 151 days
Exposure and PK of lotilaner in whole blood
Time Frame: up to 151 days
PK parameters for whole blood sampling methods following dose administration will be evaluated and include eff at various times
up to 151 days
Exposure and PK of lotilaner in whole blood
Time Frame: up to 151 days
PK parameters for whole blood sampling methods following dose administration will be evaluated and include Thalf at various times
up to 151 days
Exposure and PK of lotilaner in whole blood
Time Frame: up to 151 days
PK parameters for whole blood sampling methods following dose administration will be evaluated and include λz at various times
up to 151 days
Exposure and PK of lotilaner in whole blood
Time Frame: up to 151 days
PK parameters for whole blood sampling methods following dose administration will be evaluated and include AUC%extrap at various times
up to 151 days
Exposure and PK of lotilaner in whole blood
Time Frame: up to 151 days
PK parameters for whole blood sampling methods following dose administration will be evaluated and include MRT0-t at various times
up to 151 days
Exposure and PK of lotilaner in whole blood
Time Frame: up to 151 days
PK parameters for whole blood sampling methods following dose administration will be evaluated and include Rac at various times
up to 151 days
Exposure and PK of lotilaner in whole blood
Time Frame: up to 151 days
PK parameters for whole blood sampling methods following dose administration will be evaluated and include Ctrough at various times
up to 151 days
Urine exposure and renal PK of lotilaner
Time Frame: 3 days
PK parameters for urine sampling methods will be evaluated and include Ae.
3 days
Urine exposure and renal PK of lotilaner
Time Frame: 3 days
PK parameters for urine sampling methods will be evaluated and include fe.
3 days
Urine exposure and renal PK of lotilaner
Time Frame: 3 days
PK parameters for urine sampling methods will be evaluated and include CLr0-48.
3 days
Impact of fasting on the PK of lotilaner
Time Frame: up to 151 days
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include Cmax at various times
up to 151 days
Impact of fasting on the PK of lotilaner
Time Frame: up to 151 days
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include Tmax at various times
up to 151 days
Impact of fasting on the PK of lotilaner
Time Frame: up to 151 days
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include Tlag at various times
up to 151 days
Impact of fasting on the PK of lotilaner
Time Frame: up to 151 days
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include AUC0-168 at various times
up to 151 days
Impact of fasting on the PK of lotilaner
Time Frame: up to 151 days
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include AUC0-2880 at various times
up to 151 days
Impact of fasting on the PK of lotilaner
Time Frame: up to 151 days
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include AUC0-t at various times
up to 151 days
Impact of fasting on the PK of lotilaner
Time Frame: up to 151 days
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include AUC0-inf at various times
up to 151 days
Impact of fasting on the PK of lotilaner
Time Frame: up to 151 days
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include CL/F at various times
up to 151 days
Impact of fasting on the PK of lotilaner
Time Frame: up to 151 days
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include Vz/F at various times
up to 151 days
Impact of fasting on the PK of lotilaner
Time Frame: up to 151 days
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include Thalf at various times
up to 151 days
Impact of fasting on the PK of lotilaner
Time Frame: up to 151 days
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include λz at various times
up to 151 days
Impact of fasting on the PK of lotilaner
Time Frame: up to 151 days
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include AUC%extrap at various times
up to 151 days
Impact of fasting on the PK of lotilaner
Time Frame: up to 151 days
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include MRT0-t at various times
up to 151 days
Impact of fasting on the PK of lotilaner
Time Frame: up to 151 days
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include Rac at various times
up to 151 days
Impact of fasting on the PK of lotilaner
Time Frame: up to 151 days
PK parameters will be evaluated for lotilaner following dosing with food and under fasting conditions. Parameters include Ctrough at various times
up to 151 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tarsus Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jeremy Lim, Tarsus Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRS-013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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