NCT01249001

Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Nausea
• Vomiting
• Chemotherapy

Interventions

Type	Name	Description
DRUG	Oral Aprepitant	Subject will receive an oral suspension containing 125mg of Aprepitant
DRUG	Aprepitant	Subjects will receive a 125 mg Aprepitant capsule

Timeline

• Start date: 2010-10-01
• Primary completion: 2016-09-28
• Completion: 2016-09-28
• First posted: 2010-11-25
• Last updated: 2017-04-19

Locations

1 site across 1 country: Canada