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

• Sponsor: Inotek Pharmaceuticals Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01123772
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 9.1
• Patients Per Site Per Month: 7.7

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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 1, 2010
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [14 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 65 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Evansville	Indiana	United States

Sponsors and Collaborators

• Inotek Pharmaceuticals Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Inotek Pharmaceuticals Corporation
• ClinicalTrials.gov Identifier: NCT01123772
• Other Study ID Numbers: IPC-09-2009
• First Posted: May 14, 2010
• Last Update Posted: Apr 30, 2012
• Last Verified: Apr 1, 2012

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

Study Results

No Results Posted as of Apr 30, 2012