Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Healthy Adult Volunteers

NCT ID: NCT03245918

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-10
• Study Completion Date: 2018-01-05

Brief Summary

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. Aprepitant is commercially available in Canada as capsules. An oral liquid aprepitant formulation would be ideal for oral administration to patients unable to swallow capsules.

Conditions

Chemotherapy-induced Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Aprepitant Capsule Study Period #1

Group Type: OTHER

Aprepitant Capsule 125 MG

Intervention Type: DRUG

Patients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period

Aprepitant Oral Suspension Study Period#1

Group Type: OTHER

Aprepitant oral suspension 20 mg/mL

Intervention Type: DRUG

Patients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period

Interventions

Aprepitant Capsule 125 MG

Patients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period

Intervention Type: DRUG

Aprepitant oral suspension 20 mg/mL

Patients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male or female subjects as determined by responsible physician (see 4.3) (i.e. have no clinically significant diseases captured in the medical history, on physical examination and/or laboratory tests)
• 18 to 55 years of age
• BMI within 18.5 to 30 kg/m2
• Non-smoker
• Systolic blood pressure between 90-140 mmHg, diastolic blood pressure between 60-90 mmHg, and heart rate between 60-100 bpm, inclusive.
• Female subjects of childbearing potential should be either sexually inactive (abstinent) or be using one of acceptable methods of birth control for 15 days prior to the first dose of the study, throughout the study and for at least 30 days after the last aprepitant dose.
• Able to swallow whole aprepitant capsules
• Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer.

Exclusion Criteria

• Clinically significant illness or surgery within 8 weeks prior to dosing.
• Positive for hepatitis B, hepatitis C, or HIV at screening as per medical history.
• History of allergic reactions to the study drug and/or its excipients.
• Subjects concurrently treated with drugs that are metabolized through CYP3A4, including but not limited to pimozide, terfenadine, astemizole, or cisapride, ketoconazole, itraconazole, clarithromycin, diltiazem, warfarin, rifampin, carbamazepine, and phenytoin etc.
• History of drug or alcohol abuse within the last 6 months.
• Severe mental disorders.
• Blood donation of 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration.
• Pregnant or breastfeeding.
• Use of recreational drugs, prescription medications (other than hormonal contraceptive agents),non-prescription medications (over-the-counter) or natural health products within 7 days or 5 half-lives (whichever is longer) prior to the administration of the first dose of study medication.
• Consumed grapefruit or grapefruit products within 7 days of each study period
• Any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Lee Dupuis

Health Clinician Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

References

Patel P, Nathan PC, Walker SE, Zupanec S, Volpe J, Dupuis LL. Relative bioavailability of an extemporaneously prepared aprepitant oral suspension in healthy adults. J Oncol Pharm Pract. 2019 Dec;25(8):1907-1915. doi: 10.1177/1078155219828806. Epub 2019 Feb 5.

Reference Type: RESULT

PMID: 31694495 (View on PubMed)

Other Identifiers

1000056100

Identifier Type: -

Identifier Source: org_study_id