NCT03417999

Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease

Terminated Phase 1 Results posted Last updated 22 March 2024

What this trial tests

Phase 1 trial testing Dexmedetomidine in Dexmedetomidine in 28 participants. Terminated before completion.

Timeline

14 June 2018

Primary endpoint
12 October 2021

12 October 2021

Quick facts

Lead sponsor	Children's Hospital of Philadelphia
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	other
Enrollment	28
Start date	14 June 2018
Primary completion	12 October 2021
Estimated completion	12 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Dexmedetomidine (dexmedetomidine) — full drug profile →

Conditions studied

• Dexmedetomidine — all drugs for Dexmedetomidine →
• Congenital Heart Disease — all drugs for Congenital Heart Disease →

Sponsor

Children's Hospital of Philadelphia

Who can join

Adults 1 Month to 6, any sex, with Dexmedetomidine or Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Samples Obtained Per Subject Primary · Up to 5 hours - 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, and 300 minutes post drug administration

Following the administration of atomized intranasal dexmedetomidine, serum samples will be drawn at 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 and 300 minutes post drug administration. This is the number of samples obtained per subject.

Group	Value	95% CI
2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	10	9 – 10
2 ug/kg; Subjects Age ≥1 mo and ≤2 yo	9	7 – 9
4 μg/kg; Subjects Age >2 yo and ≤ 6 yo	10	6.5 – 10

Time of Peak Drug Concentration Level of Dexmedetomidine Primary · Up to 5 hours - 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, and 300 minutes post drug administration

Following the administration of atomized intranasal dexmedetomidine, serum samples will be drawn at 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 and 300 minutes post drug administration. The time of peak drug concentration will be determined based on this data.

Group	Value	95% CI
2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	91	44 – 120
2 ug/kg; Subjects Age ≥1 mo and ≤2 yo	30	15 – 31
4 μg/kg; Subjects Age >2 yo and ≤ 6 yo	54	45 – 106

Serum Drug Concentration Levels of Dexmedetomidine Primary · Up to 5 hours - 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, and 300 minutes post drug administration

Following administration of atomized intranasal dexmedetomidine, serum samples will be obtained at the following times post administrations: 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, and 300 minutes. Peak concentration will be determined based on this data.

Group	Value	95% CI
2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	413	311 – 565
2 ug/kg; Subjects Age ≥1 mo and ≤2 yo	570	315 – 679
4 μg/kg; Subjects Age >2 yo and ≤ 6 yo	1000	978 – 1050

Dose-limiting Toxicities (DLT) and/or Maximum Plasma Level > 1000 pg/mL Primary · Subjects were monitored for 6 hours after the administration of study drug.

Dose-limiting toxicities (DLT) include bradycardia, hypotension, new intraventricular conduction abnormality or any serious adverse event possibly, probably, or definitely related to intranasal dexmedetomidine administration that occured after the administration of the intranasal dexmedetomidine and through the completion of PK sampling. Bradycardia, hypotension, or new intraventricular conduction abnormalities that occured after the administration of intravenous dexmedetomidine given by the primary anesthesia team as part of usual clinical care were not considered DLTs but were considered an

Group	Value	95% CI
2 μg/kg; Subjects Age >2 yo and ≤ 6 yo	0
2 ug/kg; Subjects Age ≥1 mo and ≤2 yo	2
4 μg/kg; Subjects Age >2 yo and ≤ 6 yo	3

Adverse events — posted to ClinicalTrials.gov

Time frame: All subjects were monitored for 6 hours after the administration of study drug.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

2 μg/kg; Subjects Age >2 yo and ≤ 6 yo

Serious: 0/7 (0%)

Deaths: 0/7

2 ug/kg; Subjects Age ≥1 mo and ≤2 yo

Serious: 0/5 (0%)

Deaths: 0/5

4 μg/kg; Subjects Age >2 yo and ≤ 6 yo

Serious: 0/9 (0%)

Deaths: 0/9

Other adverse events (4 terms — click to expand)

Reaction	System	2 μg/kg; Subjects Age >2 y…	2 ug/kg; Subjects Age ≥1 m…	4 μg/kg; Subjects Age >2 y…
Maximum Plasma Concentration	Cardiac disorders	—	—	—
Bradycardia not requiring intervention	Cardiac disorders	—	—	—
Hypotension not requiring intervention	Cardiac disorders	—	—	—
New Intraventricular conduction delay	Cardiac disorders	—	—	—

Data from ClinicalTrials.gov NCT03417999 adverse events section.

Sponsor's own description

The main objectives of the study are to determine peak plasma drug concentration levels and corresponding time of dexmedetomidine following intranasal administration in children age ≥1 mo to ≤ 6 yr with congenital heart disease undergoing an elective diagnostic or interventional cardiac catheterization procedure.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.