A Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety of AC-170 0.24%
- Registration Number
- NCT02173249
- Lead Sponsor
- Aciex Therapeutics, Inc.
- Brief Summary
The purpose of this study is to evaluate the Plasma Pharmacokinetics and Safety of AC 170 0.24% in Healthy, Adult Subjects when used twice daily for one week.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria
- at least 18 and no older than 55 years of age
- be able to self-administer eye drops or have a parent/legal guardian available for this purpose
- have blood and urine analysis within normal limits
- have ocular health within normal limits
Exclusion Criteria
- known contraindications or sensitivities to the study medication or its components
- have any active systemic or ocular disorder (other than refractive disorder)
- have inability to comply with controlled diet
- have used prescription or non prescription drugs within washout period and throughout study
- have used alcohol or tobacco within the washout period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AC 170 0.24% AC 170 0.24% -
- Primary Outcome Measures
Name Time Method T 1/2 values of AC 170 0.24% 1 week Plasma samples will be drawn at specified time points and then analyzed to determine T 1/2 values of AC 170 0.24% in the plasma
Cmax values of AC 170 0.24% 1 week Plasma samples will be drawn at specified time points and then analyzed to determine Cmax values of AC 170 0.24% in the plasma
Tmax values of AC 170 0.24% 1 week Plasma samples will be drawn at specified time points and then analyzed to determine Tmax values of AC 170 0.24% in the plasma
AUC values of AC 170 0324% 1 week Plasma samples will be drawn at specified time points and then analyzed to determine AUC values of AC 170 0.24% in the plasma
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Andover Eye Associates
🇺🇸Andover, Massachusetts, United States