Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

Study Overview
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Brief Summary
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The primary objective of this study is to compare the absorption of a prepared aprepitant oral suspension with that of the aprepitant capsule in children being treated with chemotherapy agents that are likely to cause vomiting.

Detailed Description
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Antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and vomiting (CINV) are still common and are among the most distressing side effects of chemotherapy. In a recent survey, parents of children receiving chemotherapy in Ontario centres identified nausea as the fourth most prevalent and bothersome treatment-related symptom experienced by their children. Aprepitant is commercially available in Canada as capsules. An oral liquid aprepitant formulation would be ideal for oral administration to children.

Official Title
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Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

Conditions
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Nausea, Vomiting, Chemotherapy

Intervention / Treatment
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* Drug: Oral Aprepitant
* Drug: Aprepitant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12-18 years of age; able to swallow whole capsules; weighing ≥40kg; AST, ALT no more than 3 times the upper limit of normal for age and bilirubin concentrations within normal limits; receiving 2 consecutive (within 8 weeks) eligible, though not necessarily identical, IV chemotherapy cycles; English speaking (nausea assessment tool (PeNAT30) has been validated only in English) cognitive ability of the child believed to be at least at a 4 year old level according to parent or health care professional (to permit self-assessment of nausea severity). Exclusion Criteria: receiving very cisplatin containing chemotherapy (aprepitant capsule administration to these patients is the current standard of care at Sick Kids) receiving chemotherapy within 5 days before,during or 5 days after either study cycle that is known or suspected to interact with aprepitant; that is, cyclophosphamide, doxorubicin, daunomycin, etoposide, irinotecan, ifosfamide, imatinib, paclitaxel, topotecan, vinorelbine, vinblastine and vincristine; receiving medication known to interact with aprepitant other than dexamethasone (see Appendix I for list of applicable agents and timeframe for exclusion); Pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>This group will receive oral aprepitant on the first day of the first study cycle of chemotherapy. They will then cross-over to receive the capsule on the first day of the second study cycle of chemotherapy. | Drug: Oral Aprepitant<br>* Subject will receive an oral suspension containing 125mg of Aprepitant<br>* Other names: Emend;Drug: Aprepitant<br>* Subjects will receive a 125 mg Aprepitant capsule<br>* Other names: Emend;|
| Experimental: Group 2<br>This group will receive an aprepitant capsule on the first day of the first study cycle of chemotherapy. They will then cross-over to receive the oral aprepitant on the first day of the second study cycle of chemotherapy. | Drug: Oral Aprepitant<br>* Subject will receive an oral suspension containing 125mg of Aprepitant<br>* Other names: Emend;Drug: Aprepitant<br>* Subjects will receive a 125 mg Aprepitant capsule<br>* Other names: Emend;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability of the oral suspension relative to the capsule |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of chemotherapy-induced nausea and vomiting (CINV) | Subject will be asked to record episodes of nausea and vomiting that occur during and immediately following each chemotherapy cycle studied | 6 weeks | 
| Proportion of children with adverse effects attributable to aprepitant |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, nausea, vomiting, chemotherapy, antiemetic