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

Study Overview
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Brief Summary
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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.

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

Conditions
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Otitis Media

Intervention / Treatment
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* Drug: AL-60371 otic suspension


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ear tubes, tympanostomy tubes, Otitis Media at the time of Tympanostomy Tube surgery, OMTT