Clinical trial NCT05138861: A Six Week Pharmacokinetic Study of TP-03 in Healthy Subjects
Official title: Pharmacokinetic Study to Evaluate the Whole Blood Pharmacokinetics of TP-03 Following Six Week Topical Ocular Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Tarsus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-center, open-label, single-arm study.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: 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.
timeFrame: 42 Days
measure: 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.
timeFrame: 42 Days
measure: 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.
timeFrame: 42 Days
measure: 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.
timeFrame: 42 Days
measure: 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.
timeFrame: 42 Days
measure: 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.
timeFrame: 42 Days
measure: 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.
timeFrame: 42 Days
measure: 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.
timeFrame: 42 Days
measure: 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.
timeFrame: 42 Days
measure: 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.
timeFrame: 42 Days
measure: 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.
timeFrame: 42 Days
measure: 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.
timeFrame: 42 Days
measure: 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.
timeFrame: 42 Days
measure: 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.
timeFrame: 42 Days
measure: 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.
timeFrame: 42 Days
measure: 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.
timeFrame: 42 Days
measure: Incidence of treatment emergent adverse events (TEAEs)
timeFrame: 42 Days
measure: Clinically significant changes from Baseline chemistry laboratory tests
timeFrame: 42 Days
measure: Clinically significant changes from Baseline hematology laboratory tests
timeFrame: 42 Days
measure: Clinically significant changes from Baseline physical examinations
timeFrame: 42 Days
measure: Clinically significant changes from Baseline electrocardiograms (ECGs)
timeFrame: 42 Days
measure: Clinically significant changes from Baseline vitals
timeFrame: 42 Days
measure: Clinically significant changes from Baseline corrected distance visual acuity
timeFrame: 42 Days
measure: Clinically significant changes from Baseline non-mydriatic fundus photographs
timeFrame: 42 Days
measure: Clinically significant changes from Baseline intraocular pressure (IOP) measurement
timeFrame: 42 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Mount Royal
country: Canada
facility: Altasciences
state: Quebec
Study officials:
affiliation: Tarsus Pharmaceuticals
name: Mark Holdbrook
role: STUDY_DIRECTOR
References: