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

NCT ID: NCT05138861

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-09
• Study Completion Date: 2021-09-03

Brief Summary

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

Detailed Description

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

TP-03 (Lotilaner Ophthalmic Solution), 0.25%

TP-03, topical ocular administration in healthy adults. Single and multiple doses for 42 days.

Group Type: EXPERIMENTAL

TP-03 (Lotilaner Ophthalmic Solution), 0.25%

Intervention Type: 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.

Interventions

TP-03 (Lotilaner Ophthalmic Solution), 0.25%

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Provision of signed and dated informed consent form (ICF)

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Healthy adult male or female

4. If female, meets one of the following criteria:

1. Is of childbearing potential and agrees to use an acceptable contraceptive method.

Or

2. 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

3. 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)

5. Aged at least 18 years

6. 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)

7. 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 lactating

2. Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration

3. Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability

4. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease

5. Significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)

6. Any clinically significant illness in the 28 days prior to the first study drug administration

7. 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

8. Use of St. John's wort in the 28 days prior to the first study drug administration

9. History of any ocular surgery or laser within the past 12 months prior to the first study drug administration

10. 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

11. Presence of clinically significant ocular surface diseases including blepharitis, dry eye, corneal scars, and pterygium, or any ocular abnormalities identified at Screening

12. Presence of acute ocular infection or inflammation at Screening, or required use of eye drops

13. Any history of tuberculosis

14. Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus tests

15. Intake of an Investigational Product (IP) in the 28 days prior to the first study drug administration

16. Donation of 50 mL or more of blood in the 28 days prior to the first study drug administration

17. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tarsus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Holdbrook

Role: STUDY_DIRECTOR

Tarsus Pharmaceuticals

Locations

Altasciences

Mount Royal, Quebec, Canada

Countries

Canada

Other Identifiers

TRS-012

Identifier Type: -

Identifier Source: org_study_id