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

Hearing Loss Clinical Trial

Official title: Randomized, Placebo-controlled, Double-blind, Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC in Single Doses in Male and Female Subjects

Status Completed

Clinical Trial 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).

Clinical Trial Description

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 healthy male and female subjects between 18 and 55 years of age.

Approximately 32 subjects will be enrolled in a panel of 4 cohorts with approximately 8 subjects per cohort. There will be approximately 3 sequential ascending dosing levels of HPN-07, with each cohort administered 1 dose of HPN-07 ranging from 500 mg to 1,500 mg and the fourth cohort administered the highest tolerated dose of HPN-07 plus 1,200 mg NAC.

The primary endpoint of this trial is to establish the safety and tolerability of HPN-07 and HPN-07 plus N-acetylcysteine (NAC). Pharmacokinetics (PK) analysis of HPN-07 will enable a preliminary determination of the relationship between dose and the time course of the drug concentration in the body. Blood samples will be collected at regular intervals over the predicted time of HPN-07 systemic exposure. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Noise-Induced
• Hearing Loss, Sensorineural
• Noise-Induced Hearing Loss
• Sensorineural Hearing Loss

• NCT number: NCT02259595
• Study type: Interventional
• Source: Otologic Pharmaceutics, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: October 2014
• Completion date: February 2015