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

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Completed

CT.gov ID

NCT03245918

Collaborator

(none)

Enrollment

Location

Arms

4.9

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-induced Nausea and Vomiting	Drug: Aprepitant Capsule 125 MG Drug: Aprepitant oral suspension 20 mg/mL	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 10, 2017

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Jan 5, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Aprepitant Capsule Study Period #1	Drug: 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
Other: Aprepitant Oral Suspension Study Period#1	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

Arm

Intervention/Treatment

Other: Aprepitant Capsule Study Period #1

Drug: 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

Other: Aprepitant Oral Suspension Study Period#1

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

Outcome Measures

Primary Outcome Measures

Bioavailability of the oral suspension relative to the capsule [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lee Dupuis, Health Clinician Scientist, The Hospital for Sick Children

ClinicalTrials.gov Identifier:

NCT03245918

Other Study ID Numbers:

1000056100

First Posted:

Aug 10, 2017

Last Update Posted:

Apr 11, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Vomiting

Aprepitant

Fosaprepitant

Study Results

No Results Posted as of Apr 11, 2022