Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)

• ClinicalTrials.gov Identifier: NCT02539654
• Recruitment Status: Completed
• First Posted: September 3, 2015
• Results First Posted: July 10, 2018
• Last Update Posted: August 7, 2018
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

Brief Summary:

The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.

Condition or disease	Intervention/treatment	Phase
Otitis Media With Effusion in Children; Otitis Media Recurrent	Drug: EXE844 Sterile Otic Suspension, 0.3%; Procedure: Tympanostomy Tube Insertion	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: An Open-Label, Single-Dose, Pharmacokinetic Study of EXE844 Sterile Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery
• Actual Study Start Date: November 17, 2015
• Actual Primary Completion Date: June 24, 2016
• Actual Study Completion Date: June 24, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: EXE844; EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion	Drug: EXE844 Sterile Otic Suspension, 0.3%; Procedure: Tympanostomy Tube Insertion

Outcome Measures

Primary Outcome Measures :

1. Maximum Analyte Plasma Concentration (Cmax) [ Time Frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose ]
   Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.
2. Time to Reach Maximum Concentration (Tmax) [ Time Frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose ]
   Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.
3. Area Under the Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point (AUC0-last) [ Time Frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose ]
   Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.
4. Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) [ Time Frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose ]
   Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.
5. Time to Last Measurable Concentration (Tlast) [ Time Frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose ]
   Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.
6. Terminal Elimination Half-life (T1/2) [ Time Frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose ]
   Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion;
• Legally Authorized Representative (LAR) must read and sign the informed consent;
• Parent or caregiver must agree to complete the required study visits and comply with the requirements of the study;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Menarcheal females;
• Previous otologic or otologic-related surgery within the past 30 days or ongoing complications;
• Existing perforation of the eardrum;
• Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug;
• Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study;
• Use of prohibited medications or inadequate washout of any medication including systemic and topical antibiotics, steroids and/or analgesics;
• Weighs less than 8 kg;
• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

United States, Texas

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

Investigators

• Study Director: Clinical Manager, GCRA, Pharma; Alcon Research

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02539654
• Other Study ID Numbers: EXE844b-C003
• First Posted: September 3, 2015
• Results First Posted: July 10, 2018
• Last Update Posted: August 7, 2018
• Last Verified: November 2017

Additional relevant MeSH terms:

Otitis; Otitis Media; Otitis Media with Effusion; Ear Diseases; Otorhinolaryngologic Diseases