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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Inotek Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01123772
First received: April 27, 2010
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Health
Drug: INO-8875
Other: Placebo control
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Inotek Pharmaceuticals Corporation:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: May 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123772

Locations
United States, Indiana
Evansville, Indiana, United States
Sponsors and Collaborators
Inotek Pharmaceuticals Corporation
  More Information

No publications provided

Responsible Party: Inotek Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01123772     History of Changes
Other Study ID Numbers: IPC-09-2009
Study First Received: April 27, 2010
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014