A Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety of AC-170 0.24%

September 13, 2017 updated by: Aciex Therapeutics, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Andover Eye Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AC 170 0.24%
Drug: AC 170 0.24%
1 drop in each eye 2 times daily for 1 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax values of AC 170 0.24%
Time Frame: 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
1 week
Tmax values of AC 170 0.24%
Time Frame: 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
1 week
AUC values of AC 170 0324%
Time Frame: 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
1 week
T 1/2 values of AC 170 0.24%
Time Frame: 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
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aciex Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 13, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 14-100-0007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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