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Completed

NCT Number: NCT05138861

A Six Week Pharmacokinetic Study of TP-03 in Healthy Subjects

Pharmacokinetic Study to Evaluate the Whole Blood Pharmacokinetics of TP-03 Following Six Week Topical Ocular Administration.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences

Mount Royal, Quebec, Canada

About this study

This is a single-center, open-label, single-arm study. A single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 1 and then twice a day (in the morning and in the evening, approximately 12 hours apart) starting on Day 2 for 40 consecutive days (Days 2 to 41). Thereafter, a single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 42, for a total of 82 consecutive doses administered in each eye. The doses of Days 1, 2 (morning), 41 (evening), and 42 will be self-administered under supervision of the site staff at the clinical site. All remaining doses will be self-administered at home. Throughout the study, PK blood samples will be collected and safety assessments will be performed.

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)
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Healthy adult male or female
  • If female, meets one of the following criteria:
  • Is of childbearing potential and agrees to use an acceptable contraceptive method.

Or

  • Male partner has had a vasectomy less than 6 months prior to dosing and the female subject agrees to use an additional acceptable contraceptive method from the first study drug administration until 112 days after the last study drug administration Or
  • Is of non-childbearing potential, defined as surgically sterile (ie, has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a post-menopausal state (ie, at least 1 year without menses without an alternative medical condition prior to the first study drug administration)
  • Aged at least 18 years
  • Non- or ex-smoker (An ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration)
  • 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 lactating
  • Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration
  • Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
  • History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
  • Significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
  • Any clinically significant illness in the 28 days prior to the first study drug administration
  • Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study drug administration
  • Use of St. John's wort in the 28 days prior to the first study drug administration
  • History of any ocular surgery or laser within the past 12 months prior to the first study drug administration
  • Have used artificial eyelashes, eyelash extensions or had other cosmetic eyelash or eyelid procedures (e.g., eyeliner tattooing, eyelash tinting, eyelash curling perm, etc.) within 7 days prior to Screening or unwilling to forego their use during the study
  • Presence of clinically significant ocular surface diseases including blepharitis, dry eye, corneal scars, and pterygium, or any ocular abnormalities identified at Screening
  • Presence of acute ocular infection or inflammation at Screening, or required use of eye drops
  • Any history of tuberculosis
  • Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus tests
  • Intake of an Investigational Product (IP) in the 28 days prior to the first study drug administration
  • Donation of 50 mL or more of blood in the 28 days prior to the first study drug administration
  • Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study drug administration

Treatment and study plan

TP-03 (Lotilaner Ophthalmic Solution), 0.25%

Drug

A single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 1 and then twice a day (in the morning and in the evening, approximately 12 hours apart) starting on Day 2 for 40 consecutive days (Days 2 to 41). Thereafter, a single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 42, for a total of 82 consecutive doses administered in each eye.

Primary outcomes

  1. To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.

    Time frame: 42 Days

    The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Cmax at various times

  2. To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.

    Time frame: 42 Days

    The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Tmax at various times

  3. To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.

    Time frame: 42 Days

    The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Tlag at various times

  4. To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.

    Time frame: 42 Days

    The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC0-168 at various times

  5. To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.

    Time frame: 42 Days

    The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC0-2880 at various times

  6. To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.

    Time frame: 42 Days

    The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC0-t at various times

  7. To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.

    Time frame: 42 Days

    The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC0-inf at various times

  8. To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.

    Time frame: 42 Days

    The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner CL/F at various times

  9. To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.

    Time frame: 42 Days

    The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Vz/F at various times

  10. To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.

    Time frame: 42 Days

    The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner eff at various times

  11. To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.

    Time frame: 42 Days

    The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Thalf at various times

  12. To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.

    Time frame: 42 Days

    The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner λz at various times

  13. To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.

    Time frame: 42 Days

    The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC%extrap at various times

  14. To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.

    Time frame: 42 Days

    The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner MRT0-t at various times

  15. To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.

    Time frame: 42 Days

    The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Rac at various times

  16. To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days.

    Time frame: 42 Days

    The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Ctrough at various times

  17. Incidence of treatment emergent adverse events (TEAEs)

    Time frame: 42 Days

    Safety will be evaluated through the incidence rate of TEAEs

  18. Clinically significant changes from Baseline chemistry laboratory tests

    Time frame: 42 Days

    Evaluate the safety of TP-03 through clinically significant changes from Baseline chemistry laboratory tests

  19. Clinically significant changes from Baseline hematology laboratory tests

    Time frame: 42 Days

    Evaluate the safety of TP-03 through clinically significant changes from Baseline hematology laboratory tests

  20. Clinically significant changes from Baseline physical examinations

    Time frame: 42 Days

    Safety will be evaluated through review of clinically significant changes in physical examinations from Baseline

  21. Clinically significant changes from Baseline electrocardiograms (ECGs)

    Time frame: 42 Days

    Safety will be evaluated through review of clinically significant changes in electrocardiograms from Baseline

  22. Clinically significant changes from Baseline vitals

    Time frame: 42 Days

    Safety will be evaluated through review of 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]) from Baseline

  23. Clinically significant changes from Baseline corrected distance visual acuity

    Time frame: 42 Days

    Safety will be evaluated through review of clinically significant changes in corrected distance visual acuity from Baseline

  24. Clinically significant changes from Baseline non-mydriatic fundus photographs

    Time frame: 42 Days

    Safety will be evaluated through review of clinically significant changes in non-mydriatic fundus photographs from Baseline

  25. Clinically significant changes from Baseline intraocular pressure (IOP) measurement

    Time frame: 42 Days

    Safety will be evaluated through review of clinically significant changes in IOP from Baseline

Sponsors and collaborators

Lead sponsor

Tarsus Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Pharmacokinetic Study to Evaluate the Whole Blood Pharmacokinetics of TP-03 Following Six Week Topical Ocular Administration

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 1, 2021
Registry last updated
Apr 12, 2024

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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