NCT02259595

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Otologic Pharmaceutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-01-01
• Completion: 2015-02-01
• First posted: 2014-10-08
• Last updated: 2015-05-01

Locations

1 site across 1 country: United States