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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Otitis Media
• Intervention / Treatment: Drug: AL-60371 otic suspension

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AL-60371/Posology 1; AL-60371 otic suspension, single dose of 200 µL following surgical insertion of tympanostomy tubes	Drug: AL-60371 otic suspension
Experimental: AL-60371/Posology 2; AL-60371 otic suspension, single dose of 4 drops following surgical insertion of tympanostomy tubes	Drug: AL-60371 otic suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Area under the concentration-time curve from 0 to infinity (AUC0-∞)	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
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
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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Celeste McClean, BS, MT (ASCP), Alcon Research

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): January 1, 2015

Study Registration Dates

• First Submitted: July 24, 2013
• First Submitted That Met QC Criteria: July 24, 2013
• First Posted (Estimate): July 26, 2013

Study Record Updates

• Last Update Posted (Estimate): March 8, 2016
• Last Update Submitted That Met QC Criteria: March 4, 2016
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: ear tubes; tympanostomy tubes; Otitis Media at the time of Tympanostomy Tube surgery; OMTT
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: C-13-023