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Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC

NCT02259595 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-05-01

No results posted yet for this study

Summary

This study is a single-center, randomized, placebo-controlled, double-blind, single ascending dose escalation study to determine the safety, tolerability, and PK profile of oral administration of HPN-07 in single doses to approximately 32 healthy male and female subjects between 18 and 55 years of age.

Subjects will receive single oral doses of the study drug. The primary endpoint of this trial is to establish the safety and tolerability of HPN-07 and HPN-07 plus N-acetylcysteine (NAC).

Conditions

  • Hearing Loss
  • Sensorineural Hearing Loss
  • Noise-Induced Hearing Loss

Interventions

DRUG

HPN-07

500-1,500 mg oral capsules administered in a single dose

DRUG

NAC

1,200mg NAC administered via oral capsule in single dose

DRUG

Placebo

placebo oral capsule

Sponsors & Collaborators

  • Otologic Pharmaceutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Treva Tyson, MD · Wake Research Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-01-31
Completion
2015-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02259595 on ClinicalTrials.gov