Clinical trial · Interventional
Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects
Ascending Single-Dose Of The Safety, Tolerability, And Pharmacokinetics Of Bosutinib Administered Orally With Multiple Doses Of Ketoconazole To Healthy Adult Subjects.
NCT00777530CI-TRIAL-00001746completedPhase 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)
The purpose of this study is to assess the safety and tolerability of ascending single oral doses of bosutinib administered with multiple doses of ketoconazole and to provide the pharmacokinetic profile of bosutinib when administered with multiple doses of ketoconazole and with food in healthy adult subjects.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bosutinib (SKI-606) | Drug | Bosutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Bosutinib (SKI-606)
Primary outcomes (1)
- measure
- Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests.
- timeFrame
- 5 weeks
Secondary outcomes (1)
- measure
- Blood samples
- timeFrame
- 5 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion criteria: 1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive on study day 1. WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥ 1 year (with follicle-stimulating hormone \[FSH\] ≥ 38 mIU/mL) and must have a negative serum pregnancy test result before administration of test article. 2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥ 50 kg. 3. Healthy as determined by the investigator on the basis of screening evaluations. Exclusion criteria: 1. Family history QT prolongation, syncope, seizure, or unexplained cardiac related death. 2. Presence or history of any disorder that may prevent the successful completion of the study. 3. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
References
Publications (1)
- DERIVEDAbbas R, Leister C, El Gaaloul M, Chalon S, Sonnichsen D. Ascending single-dose study of the safety profile, tolerability, and pharmacokinetics of bosutinib coadministered with ketoconazole to healthy adult subjects. Clin Ther. 2012 Sep;34(9):2011-9.e1. doi: 10.1016/j.clinthera.2012.07.006. Epub 2012 Aug 9. PMID 22884766