Pharmacokinetic Study to Evaluate the Whole Blood Pharmacokinetics of TP-03 Following Six Week Topical Ocular Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
Pharmacokinetic Study to Evaluate the Whole Blood Pharmacokinetics of TP-03 Following Six Week Topical Ocular Administration.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
No masking procedure is required as this is an open-label study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •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
排除标准
- •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
研究组 & 干预措施
TP-03 (Lotilaner Ophthalmic Solution), 0.25%
TP-03, topical ocular administration in healthy adults. Single and multiple doses for 42 days.
干预措施: TP-03 (Lotilaner Ophthalmic Solution), 0.25% (Drug)
结局指标
主要结局
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.
时间窗: 42 Days
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Ctrough at various times
Clinically significant changes from Baseline hematology laboratory tests
时间窗: 42 Days
Evaluate the safety of TP-03 through clinically significant changes from Baseline hematology laboratory tests
Incidence of treatment emergent adverse events (TEAEs)
时间窗: 42 Days
Safety will be evaluated through the incidence rate of TEAEs
Clinically significant changes from Baseline physical examinations
时间窗: 42 Days
Safety will be evaluated through review of clinically significant changes in physical examinations from Baseline
Clinically significant changes from Baseline chemistry laboratory tests
时间窗: 42 Days
Evaluate the safety of TP-03 through clinically significant changes from Baseline chemistry laboratory tests
Clinically significant changes from Baseline electrocardiograms (ECGs)
时间窗: 42 Days
Safety will be evaluated through review of clinically significant changes in electrocardiograms from Baseline
Clinically significant changes from Baseline vitals
时间窗: 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
Clinically significant changes from Baseline corrected distance visual acuity
时间窗: 42 Days
Safety will be evaluated through review of clinically significant changes in corrected distance visual acuity from Baseline
Clinically significant changes from Baseline non-mydriatic fundus photographs
时间窗: 42 Days
Safety will be evaluated through review of clinically significant changes in non-mydriatic fundus photographs from Baseline
Clinically significant changes from Baseline intraocular pressure (IOP) measurement
时间窗: 42 Days
Safety will be evaluated through review of clinically significant changes in IOP from Baseline
次要结局
未报告次要终点