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

Phase 1

Withdrawn

• Conditions: Otitis Media
• Interventions: Drug: AL-60371 otic suspension

• Registration Number: NCT01908764
• Lead Sponsor: Alcon Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-26
• Status Verified: 2014-10
• Study Start: 2014-11
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2016-03-04
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AL-60371/Posology 1	AL-60371 otic suspension	AL-60371 otic suspension, single dose of 200 µL following surgical insertion of tympanostomy tubes
AL-60371/Posology 2	AL-60371 otic suspension	AL-60371 otic suspension, single dose of 4 drops following surgical insertion of tympanostomy tubes

Primary Outcome Measures

Name	Time	Method
The terminal elimination half (T½)	Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose	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).
Maximum observed analyte plasma concentration (Cmax)	Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose	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).
Time to reach Cmax (Tmax)	Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose	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).
Area under the analyte plasma concentration-time curve to the last quantifiable sampling time point (AUC0-last)	Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose	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).
Area under the concentration-time curve from 0 to infinity (AUC0-∞)	Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose	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).
Time to last measurable concentration (Tlast)	Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose	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).