The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive opioids.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
24
Administered as an oral tablet (0.2 mg dose level only), or oral suspension (all dose levels)
University Center Mother Theresa , Hospital - Onco-hematology department
Tirana, Albania
NOT_YET_RECRUITINGMaximum Plasma Concentration (Cmax) of Naldemedine and Nor-naldemedine
Time frame: Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
Time to Achieve Maximum Plasma Concentration (Tmax) of Naldemedine and Nor-naldemedine
Time frame: Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of Naldemedine and Nor-naldemedine
Time frame: Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
AUC Extrapolated From Time Zero to Infinity (AUC0-inf) of Naldemedine and Nor-naldemedine
Time frame: Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
Terminal Elimination Rate Constant (λz) of Naldemedine and Nor-naldemedine
Time frame: Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
Terminal Elimination Half-life (t1/2,z) of Naldemedine and Nor-naldemedine
Time frame: Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
Apparent Total Clearance (CL/F) of Naldemedine
Time frame: Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
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Yeolyan Hematology. , and Oncology Center -
Yerevan, Armenia
RECRUITINGCHU Saint-Pierre Clinical Trials Unit
Brussels, Belgium
COMPLETEDUniversitair Ziekenhuis Brussel (UZBrussel) - Department of Anesthesiology and Perioperative Medicine
Brussels, Belgium
COMPLETEDUniversity Hospitals Leuven Pediatrisch hemato-oncology
Leuven, Belgium
COMPLETEDUniversity Clinical Hospital , Mostar
Mostar, Bosnia and Herzegovina
RECRUITINGChu de Caen
Caen, France
COMPLETEDHôpital Béclère Service de Pédiatrie Centre de Référence des Maladies Héréditaires du Métabolisme Hépatique (CRMHMH)
Clamart, France
COMPLETEDHôpital Jeanne de Flandre Antenne du CIC pédiatrique - Niveau 0 CHU de Lille
Lille, France
COMPLETEDHôpital Armand Trousseau Service Hématologie et Oncologie Pédiatrique
Paris, France
COMPLETED...and 6 more locations
Mean Residence Time (MRT) of Naldemedine
Time frame: Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
Apparent Volume of Distribution in the Terminal Phase (Vz/F) of Naldemedine
Time frame: Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
Metabolic Ratio of Cmax of Nor-naldemedine to Cmax of Naldemedine (MRM/U, Cmax) for Nor-naldemedine
Time frame: Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
Metabolic Ratio of AUC of Nor-naldemedine to AUC of Naldemedine (MRM/U, AUC) for Nor-naldemedine
Time frame: Day 1: 0.5, 1, 5, and 12 hours postdose; Day 2: 24 hours post Day 1 dose, before administering the Day 2 dose; Day 7 (Cohort 1 only): Predose and 1 hour postdose
Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Day 7
Population PK Analysis: Cmax of Naldemedine
Time frame: Day 1 through Day 7
Population PK Analysis: Tmax of Naldemedine
Time frame: Day 1 through Day 7
Population PK Analysis: AUC From Time Zero to tau (AUC0-tau) of Naldemedine
Time frame: Day 1 through Day 7
Population PK Analysis: Accumulation Ratio for Cmax Calculated as Ratio of Day 7 to Day 1 Cmax (RCmax) of Naldemedine
Time frame: Day 1 through Day 7
Population PK Analysis: Accumulation Ratio for AUC Calculated as Ratio of Day 7 to Day 1 AUC (RAUC) of Naldemedine
Time frame: Day 1 through Day 7
Palatability of Naldemedine Powder for Oral Suspension in Participants Aged 6 Years and Above
Palatability will be assessed by participant self-reporting using a visual analogue scale (VAS).
Time frame: Day 1 through Day 7
Palatability of Naldemedine Powder for Oral Suspension in Participants Aged 2 to Less Than 6 Years
Palatability will be assessed by the investigator or a participant's parent/legal guardian and, if possible, by participant self-reporting using a VAS with facial hedonic scale.
Time frame: Day 1 through Day 7
Ability to Swallow Naldemedine Tablets
Ability to swallow will be assessed by self-reported ease of swallowing after the first dose. Willingness to swallow will be assessed based on the participant's behavior indicative of a negative response and the response to the taste of naldemedine powder for oral suspension formulation compared to the participant's response to all other oral medications currently being given.
Time frame: Day 1 through Day 7