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

NCT02539654 | Completed Phase 1 Results

• 1 other identifier: EXE844b-C003
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Otitis Media With Effusion in Children; Otitis Media Recurrent

Outcome Measures

Primary Outcomes (6)

• Maximum Analyte Plasma Concentration (Cmax)

  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.

  Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

• Time to Reach Maximum Concentration (Tmax)

  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.

  Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

• Area Under the Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point (AUC0-last)

  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.

  Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

• Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf)

  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.

  Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

• Time to Last Measurable Concentration (Tlast)

  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.

  Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

• Terminal Elimination Half-life (T1/2)

  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.

  Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

Study Arms (1)

EXE844

EXPERIMENTAL

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

Interventions

EXE844 Sterile Otic Suspension, 0.3% DRUG

EXE844

Tympanostomy Tube Insertion PROCEDURE

EXE844

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Interventions

Middle Ear Ventilation

Intervention Hierarchy (Ancestors)

Ostomy; Surgical Procedures, Operative; Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures

Results Point of Contact

• Title: Clinical Scientific Director, GCRA
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, GCRA, Pharma

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 3, 2015
• Study Start: November 17, 2015
• Primary Completion: June 24, 2016
• Study Completion: June 24, 2016
• Last Updated: August 7, 2018
• Results First Posted: July 10, 2018

Record last verified: 2017-11

Locations

US (1)