Overview
Protective Effects of EPI-743 on Noise-Induced Hearing Loss
Status:
Completed
Completed
Trial end date:
2016-02-29
2016-02-29
Target enrollment:
0
0
Participant gender:
All
All
Summary
If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.Phase:
Phase 2Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Edison Pharmaceuticals IncTreatments:
Ubiquinone
Criteria
Inclusion Criteria:- Healthy adults ages 18-30
- Abstention from use of Idebenone, CoQ10, Vitamin E and foods or beverages at least 30
days prior to treatment initiation
- Non-smokers
- Abstention from alcohol from day 0 and throughout the duration of study
- Normal audiology exam
- Subject must be able to swallow size 0 capsules
Exclusion Criteria:
- Allergy to EPI-743 or sesame oil or nuts
- Any medical disordere that would prevent subject participation
- Any prescription meds other than for contraception or seasonal allergies
- Any significant patient medical history (cancer, cardiovascular, pulmonary, cognitive,
ADHD, hx. of migraines, neurological, kidney)
- Fat malabsorption syndromes
- Anticoagulation thereapy within 30 days of enrollment