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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
History of Changes
  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
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 June 18, 2013