Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery

Otitis Media Clinical Trial

Official title:

An Open-Label, Single Dose, Pharmacokinetic Study of AL-60371 Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01908764
• Other study ID #: C-13-023
• Status: Withdrawn
• Phase: Phase 1
• First received: July 24, 2013
• Last updated: March 4, 2016
• Start date: November 2014
• Est. completion date: January 2015

Study information

• Verified date: October 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to describe the pharmacokinetics of AL-60371 otic suspension following two posologies of bilateral ototopical doses in pediatric subjects immediately after bilateral tympanostomy tube surgery.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 12 Years

Eligibility

Inclusion Criteria:

• Requires bilateral myringotomy and tympanostomy tube insertion;

• Provides informed consent (parent/legal guardian);

• Signs assent form where applicable (subject);

• Accompanied by parent/legal guardian at each visit;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Menarcheal females;

• Current or recent history of any disease which, in the opinion of the Principal Investigator, may place the subject at risk or interfere with study;

• Use of excluded medications within one week prior to surgery and for the duration of the study;

• Requires another surgical procedure in addition to the myringotomy;

• Clinically relevant otic condition which, in the opinion of the Principal Investigator, would preclude the safe administration of the study medication;

• Participation in any other investigational study within 30 days before entry into this study or along with this study;

• Known or suspected allergy or hypersensitivity to any active or inactive ingredient in the test article;

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Otitis Media

Intervention

Drug:
• AL-60371 otic suspension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed analyte plasma concentration (Cmax)	The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).	Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose	No
Primary	Time to reach Cmax (Tmax)	The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).	Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose	No
Primary	Area under the analyte plasma concentration-time curve to the last quantifiable sampling time point (AUC0-last)	The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).	Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose	No
Primary	Area under the concentration-time curve from 0 to infinity (AUC0-8)	The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).	Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose	No
Primary	Time to last measurable concentration (Tlast)	The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).	Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose	No
Primary	The terminal elimination half (T½)	The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).	Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose	No