Ignite Creation Date:
2024-05-06 @ 3:19 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02259595
Status:
COMPLETED
Last Update Posted:
2015-05-01
First Post:
2014-09-02
Brief Title:
Study to Determine the Safety Tolerability and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC
Sponsor:
Otologic Pharmaceutics Inc
Organization:
Otologic Pharmaceutics Inc
Study Overview
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
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 1500 mg and the fourth cohort administered the highest tolerated dose of HPN-07 plus 1200 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
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 1500 mg and the fourth cohort administered the highest tolerated dose of HPN-07 plus 1200 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None