Clinical trial NCT00819039: A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)
Official title: A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-01-08
Enrollment: 98
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This two part study will determine the appropriate dosing regimen of aprepitant for the prevention of postoperative nausea and vomiting (PONV) in pediatric participants 6 months to 17 years of age, by assessing pharmacokinetic parameters and monitoring safety and tolerability of administered doses. Part I will be an open label investigation of a single dose of aprepitant measuring pharmacokinetics at specified time points up to 48 hours after aprepitant dosing. Part II will be a double blind trial of participants randomized to receive either aprepitant or ondansetron.


Eligibility criteria: Inclusion Criteria:

* Participant is scheduled to have surgery requiring a 48 hour (Part I) or 24 hour (Part II) hospital stay
* Participant is scheduled to receive general anesthesia
* Participant is scheduled to receive opioids (e.g. morphine or fentanyl)
* Female participants of childbearing potential must have negative pregnancy test prior to drug administration
* A female participant who is of reproductive potential must agree to remain abstinent or use a barrier form of contraception for at least 14 days prior to, throughout, and for at least one month following the last dose of study medication
* Participant weighs 6 kg or more

Exclusion Criteria:

* Participant is undergoing surgery for a life-threatening condition
* Participant is pregnant or breast feeding
* Participant has vomited within 24 hours prior to surgery
* Participant has a known history of QT prolongation or is currently taking other medicinal products that lead to QT prolongation
* Participant has an active infection (e.g., pneumonia), congestive heart failure, bradyarrythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction), evidence of any clinically significant respiratory, metabolic, hepatic, renal dysfunction, or a history of any illness, including morbid obesity, that might pose unwarranted risk

Primary outcomes:
measure: Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1
timeFrame: Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose
measure: Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1
timeFrame: 48 Hours Post-Dose
measure: Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1
timeFrame: 48 Hours Post-Dose
measure: Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1
timeFrame: 24 Hours Post-Dose
measure: Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1
timeFrame: 48 Hours Post-Dose
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to 21 Days Post-Surgery
measure: Number of Participants Discontinuing Study Treatment Due to AEs
timeFrame: Day 1
Secondary outcomes:
measure: Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2
timeFrame: Up to 24 Hours
measure: Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2
timeFrame: Up to 24 Hours
measure: Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2
timeFrame: Up to 48 Hours
measure: Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2
timeFrame: Up to 48 Hours
measure: Number of Participants With Vomiting Frequency in Study Part 2
timeFrame: Up to 24 Hours
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Call for Information (Investigational Site 0003)
state: Kentucky
city: Nashville
country: United States
facility: Call for Information (Investigational Site 0022)
state: Tennessee
city: Sao Paulo
country: Brazil
facility: MSD
state: SP
city: Mexico City
country: Mexico
facility: MSD
city: Madrid
country: Spain
facility: Merck Sharp and Dohme de Espana S.A.
city: Istanbul
country: Turkey
facility: Merck Sharp & Dohme Ilaclari Ltd. Sti
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Chain A, Wrishko R, Vasilinin G, Mouksassi S. Modeling and Simulation Analysis of Aprepitant Pharmacokinetics in Pediatric Patients With Postoperative or Chemotherapy-Induced Nausea and Vomiting. J Pediatr Pharmacol Ther. 2020;25(6):528-539. doi: 10.5863/1551-6776-25.6.528.