NCT03245918

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

August 10, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2018

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

August 8, 2017

Last Update Submit

April 1, 2022

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • Bioavailability of the oral suspension relative to the capsule

    6 weeks

Study Arms (2)

Aprepitant Capsule Study Period #1

OTHER
Drug: Aprepitant Capsule 125 MG

Aprepitant Oral Suspension Study Period#1

OTHER
Drug: Aprepitant oral suspension 20 mg/mL

Interventions

Aprepitant Capsule 125 MGDRUG

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 Capsule Study Period #1
Aprepitant oral suspension 20 mg/mLDRUG

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

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 31694495RESULT

MeSH Terms

Conditions

Vomiting

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Health Clinician Scientist

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 10, 2017

Study Start

August 10, 2017

Primary Completion

December 31, 2017

Study Completion

January 5, 2018

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)