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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 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 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.


Sponsor: Otologic Pharmaceutics, Inc.

Current Primary Outcome: Safety and tolerability of single doses of HPN-07, alone and in co-administration with NAC: Adverse events [ Time Frame: 48 hours ]

The primary endpoint of this trial is to establish the safety and tolerability of HPN-07 and HPN-07 plus NAC. The following safety parameters will be evaluated for adverse events as determined by: 12-lead ECG, clinical laboratory tests, urinalysis, and vital signs.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Area under the curve (AUC) of single doses of HPN-07, alone and in co-administration with NAC [ Time Frame: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing ]
  • Maximum observed plasma concentration (Cmax) of single doses of HPN-07, alone and in co-administration with NAC [ Time Frame: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing ]
  • Half life (t1/2) of single doses of HPN-07, alone and in co-administration with NAC [ Time Frame: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing ]
  • Volume of distribution (Vz) of single doses of HPN-07, alone and in co-administration with NAC [ Time Frame: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing ]
  • Mean transit time (MTT) of single doses of HPN-07, alone and in co-administration with NAC [ Time Frame: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing ]
  • Total clearance (CL) of single doses of HPN-07, alone and in co-administration with NAC [ Time Frame: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing ]


Original Secondary Outcome: Same as current

Information By: Otologic Pharmaceutics, Inc.

Dates:
Date Received: September 2, 2014
Date Started: October 2014
Date Completion:
Last Updated: April 29, 2015
Last Verified: April 2015