Chemotherapy-induced Nausea and Vomiting
Conditions
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.
Interventions
DRUGAprepitant 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
DRUGAprepitant 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
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioavailability of the oral suspension relative to the capsule | 6 weeks |
Countries
Canada
Outcome results
None listed