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Completed

NCT Number: NCT02173249

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AC 170 0.24%

Drug

1 drop in each eye 2 times daily for 1 week

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Aciex Therapeutics, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 24, 2014
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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