Health Trials

Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

ConditionOpioid-Induced Constipation (OIC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age2-18
SponsorShionogi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with cancer or non-cancer pain who are receiving (or who are about to receive) acute or chronic treatment with opioids.

Participants with either newly diagnosed constipation, a history of constipation treated with laxatives, or are expected to develop constipation after opioid treatment.

Able to remain in the clinic for blood sampling for at least 12 hours following the first study intervention dose and are able to return for blood sampling at the 24-hour time point.

Body mass index within approximately the 3rd to 97th percentile for their age according to the World Health Organization Child Growth Standards.

Disqualifiers

History of a gastrointestinal (GI) neoplasm or an ongoing GI-related issue or any recent (within last 1 year) or planned GI tract surgery.

Signs or symptoms of GI obstruction or participants with recurrent obstruction who may be at increased risk of GI perforation.

Inability to eat/swallow or have need of a nasogastric tube.

No bowel movements reported for 7 consecutive days at the time of obtaining informed consent or on the initial day of study intervention administration (Study Day 1).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Naldemedine

    Drug

    Administered as an oral tablet (0.2 mg dose level only), or oral suspension (all dose levels)

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Cohort 1: ≥ 12 to < 18 YearsExperimental treatment 1 intervention
Group B: Cohort 2: ≥ 6 to < 12 YearsExperimental treatment 1 intervention
Group C: Cohort 3: ≥ 2 to < 6 YearsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum 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
2

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
3

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
4

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

Secondary outcomes

1

Number of Participants Experiencing Treatment-emergent Adverse Events

Time frame
Day 1 through Day 7
2

Population PK Analysis: Cmax of Naldemedine

Time frame
Day 1 through Day 7
3

Population PK Analysis: Tmax of Naldemedine

Time frame
Day 1 through Day 7
4

Population PK Analysis: AUC From Time Zero to tau (AUC0-tau) of Naldemedine

Time frame
Day 1 through Day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shionogi

Lead sponsor

Source ClinicalTrials.gov
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