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Completed

NCT Number: NCT05138796

A Pharmacokinetic Study 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

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Key information

Conditions

Healthy

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences

Overland Park, Kansas, 66212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent form (ICF)
  • 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

  • Female who is pregnant or lactating
  • Presence or history of significant gastrointestinal, metabolic, liver or kidney disease, or surgery that may affect drug bioavailability (excluding appendectomy and cholecystectomy)
  • History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
  • Have a history of a malignancy (or active malignancy), with the exception of treated basal cell or squamous cell carcinoma
  • 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
  • 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)
  • Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg) or Hepatitis C Antibody (HCVAb)
  • Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to Screening
  • Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening
  • Plasma donation within 7 days prior to screening

Treatment and study plan

TP-05 (lotilaner oral capsules)

Drug

TP-05 (lotilaner oral capsules)

Placebo

Drug

Placebo to match TP-05 (lotilaner oral capsules)

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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)

  12. 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

  13. 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])

  14. 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]

  15. 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]

  16. 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]

  17. 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])

  18. 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])

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. Urine exposure and renal PK of lotilaner

    Time frame: 3 days

    PK parameters for urine sampling methods will be evaluated and include Ae.

  18. Urine exposure and renal PK of lotilaner

    Time frame: 3 days

    PK parameters for urine sampling methods will be evaluated and include fe.

  19. Urine exposure and renal PK of lotilaner

    Time frame: 3 days

    PK parameters for urine sampling methods will be evaluated and include CLr0-48.

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

Sponsors and collaborators

Lead sponsor

Tarsus Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 1, 2021
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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