Trial Outcomes & Findings for Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT) (NCT NCT02539654)
NCT ID: NCT02539654
Last Updated: 2018-08-07
Results Overview
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.
COMPLETED
PHASE1
14 participants
Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
2018-08-07
Participant Flow
Participants were recruited from 2 investigational sites located in the US.
All 14 enrolled participants were treated. This reporting group includes all enrolled participants (14).
Participant milestones
| Measure |
EXE844
EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)
Baseline characteristics by cohort
| Measure |
EXE844
n=14 Participants
EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion
|
|---|---|
|
Age, Continuous
|
3.4 years
STANDARD_DEVIATION 2.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dosePopulation: PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte \[EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)\]
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.
Outcome measures
| Measure |
EXE844
n=14 Participants
EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion
|
|---|---|
|
Maximum Analyte Plasma Concentration (Cmax)
AL-60371
|
2.44 ng/mL
Standard Deviation 2.411
|
|
Maximum Analyte Plasma Concentration (Cmax)
AL-91591
|
1.61 ng/mL
Standard Deviation 1.141
|
PRIMARY outcome
Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dosePopulation: PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte \[EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)\]
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.
Outcome measures
| Measure |
EXE844
n=14 Participants
EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion
|
|---|---|
|
Time to Reach Maximum Concentration (Tmax)
AL-60371
|
0.59 hours
Interval 0.48 to 2.1
|
|
Time to Reach Maximum Concentration (Tmax)
AL-91591
|
1.00 hours
Interval 0.55 to 2.17
|
PRIMARY outcome
Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dosePopulation: PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte \[EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)\]
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.
Outcome measures
| Measure |
EXE844
n=9 Participants
EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion
|
|---|---|
|
Area Under the Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point (AUC0-last)
AL-60371
|
8.66 ng*h/mL
Standard Deviation 6.406
|
|
Area Under the Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point (AUC0-last)
AL-91591
|
3.94 ng*h/mL
Standard Deviation 4.136
|
PRIMARY outcome
Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dosePopulation: PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte \[EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)\]
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.
Outcome measures
| Measure |
EXE844
n=8 Participants
EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion
|
|---|---|
|
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf)
AL-60371
|
10.60 ng*h/mL
Standard Deviation 7.764
|
|
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf)
AL-91591
|
19.90 ng*h/mL
Standard Deviation NA
Unable to compute estimate
|
PRIMARY outcome
Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dosePopulation: PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte \[EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)\]
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.
Outcome measures
| Measure |
EXE844
n=11 Participants
EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion
|
|---|---|
|
Time to Last Measurable Concentration (Tlast)
AL-60371
|
5.90 hours
Interval 1.08 to 6.1
|
|
Time to Last Measurable Concentration (Tlast)
AL-91591
|
2.17 hours
Interval 1.0 to 5.95
|
PRIMARY outcome
Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dosePopulation: PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte \[EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)\]
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.
Outcome measures
| Measure |
EXE844
n=8 Participants
EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion
|
|---|---|
|
Terminal Elimination Half-life (T1/2)
AL-91591
|
4.42 hours
Standard Deviation NA
Unable to compute estimate
|
|
Terminal Elimination Half-life (T1/2)
AL-60371
|
2.05 hours
Standard Deviation 0.821
|
Adverse Events
Pre-treatment
EXE844
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Scientific Director, GCRA
Alcon, A Novartis Division
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER