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Phase I Dose-Escalation Study to Evaluate Tolerability, Safety & PK of INO-8875 in Healthy Older-Adult Volunteers

NCT ID: NCT01123772

Last Updated: 2012-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-02-28

Brief Summary

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The purpose of this study is to evaluate how tolerable and safe it is to give INO-8875 eye drops at different concentrations to normal older healthy adult volunteers for two weeks.

Detailed Description

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Conditions

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Health

Keywords

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adenosine agonist eye drop elderly volunteer older healthy volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Vehicle control

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type OTHER

Matched placebo

INO-8875

Active drug

Group Type EXPERIMENTAL

INO-8875

Intervention Type DRUG

eye drops for 14 days in one eye

Interventions

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INO-8875

eye drops for 14 days in one eye

Intervention Type DRUG

Placebo control

Matched placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* male, or a female with a negative pregnancy test and without childbearing potential
* aged 35 to 65 years
* body weight is ≥50 kg and ≤115 kg

Exclusion Criteria

* Subject has glaucoma or any active ophthalmologic disease including conjunctivitis
* Subject has a central retinal vein occlusion in either eye at any time in the past
* Subject is currently on any drug that might affect IOP including oral or ocular glucocorticoids or ephedrine
* Subject has history of ocular trauma or surgery (except for non-incisional surgery performed at least 3 months prior to the Screening visit)
* Subject has a prosthetic eye or any ocular abnormality precluding reliable applanation tonometry in either eye including an immobile pupil.
* Subject is not able to refrain from use of contact lenses during the Treatment Period
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inotek Pharmaceuticals Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Evansville, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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IPC-09-2009

Identifier Type: -

Identifier Source: org_study_id