Clinical trial · Interventional
A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy Volunteers
An Open-Label, Randomized, 2-Period Crossover Study To Evaluate The Effect Of A Single Dose Of Aprepitant, A Moderate CYP3A Inhibitor On Bosutinib Administered Orally To Healthy Subjects
NCT02058277CI-TRIAL-00014919completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open label, randomized, single dose, one cohort, two sequence, two period crossover study in healthy subjects. The primary objective of the study is to evaluate the effect of a single oral dose of aprepitant on the pharmacokinetic (PK) profile of a single oral dose of bosutinib in healthy subjects.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bosutinib or bosutinib + aprepitant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Healthy volunteers
- description
- Healthy volunteers taking a single dose of bosutinib and a single dose of bosutinib plus aprepitant in random order
- interventionNames
- Drug: bosutinib or bosutinib + aprepitant
Primary outcomes (2)
- measure
- Area under the Concentration-Time Curve (AUC)
- timeFrame
- 96 hours
- description
- AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
- measure
- Maximum Observed Plasma Concentration (Cmax)
- timeFrame
- 96 hours
- description
- Cmax is the peak concentration.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy male and/or female subjects with an informed consent document signed and dated by the subject. Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease * Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non hormonal contraception as outlined in this protocol . * Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication.
References
Publications (1)
- DERIVEDHsyu PH, Pignataro DS, Matschke K. Effect of aprepitant, a moderate CYP3A4 inhibitor, on bosutinib exposure in healthy subjects. Eur J Clin Pharmacol. 2017 Jan;73(1):49-56. doi: 10.1007/s00228-016-2108-z. Epub 2016 Oct 7. PMID 27718000