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

Conditions

Otitis Media Recurrent, Otitis Media With Effusion in Children

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.

Related papers

No related papers found yet.

Interventions

DRUGEXE844 Sterile Otic Suspension, 0.3%

PROCEDURETympanostomy Tube Insertion

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 12 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Maximum Analyte Plasma Concentration (Cmax)	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.
Time to Reach Maximum Concentration (Tmax)	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.
Area Under the Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point (AUC0-last)	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.
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf)	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.
Time to Last Measurable Concentration (Tlast)	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.
Terminal Elimination Half-life (T1/2)	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.

Countries

United States

Participant flow

Recruitment details

Participants were recruited from 2 investigational sites located in the US.

Pre-assignment details

All 14 enrolled participants were treated. This reporting group includes all enrolled participants (14).

Participants by arm

Arm	Count
EXE844 EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion	14
Total	14

Baseline characteristics

Characteristic	EXE844
Age, Continuous	3.4 years STANDARD_DEVIATION 2.78
Sex: Female, Male Female	6 Participants
Sex: Female, Male Male	8 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 14	0 / 14
other Total, other adverse events	0 / 14	0 / 14
serious Total, serious adverse events	0 / 14	0 / 14

Outcome results

Primary

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.

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