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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01123772
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : April 30, 2012
Information provided by (Responsible Party):
Inotek Pharmaceuticals Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Health Drug: INO-8875 Other: Placebo control Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation Study to Evaluate Tolerability, Safety & PK of BID Topical Ocular Application of INO-8875 in Healthy Older-Adult Volunteers
Study Start Date : May 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Arm Intervention/treatment
Placebo Comparator: Control
Vehicle control
Other: Placebo control
Matched placebo

Experimental: INO-8875
Active drug
Drug: INO-8875
eye drops for 14 days in one eye

Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01123772

United States, Indiana
Evansville, Indiana, United States
Sponsors and Collaborators
Inotek Pharmaceuticals Corporation

Responsible Party: Inotek Pharmaceuticals Corporation Identifier: NCT01123772     History of Changes
Other Study ID Numbers: IPC-09-2009
First Posted: May 14, 2010    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: April 2012

Keywords provided by Inotek Pharmaceuticals Corporation:
adenosine agonist
eye drop
elderly volunteer
older healthy volunteer

Additional relevant MeSH terms:
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action