Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects
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ClinicalTrials.gov Identifier: NCT00777530 |
Recruitment Status :
Completed
First Posted : October 22, 2008
Last Update Posted : October 23, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Tumors Leukemia | Drug: Bosutinib (SKI-606) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Official Title: | Ascending Single-Dose Of The Safety, Tolerability, And Pharmacokinetics Of Bosutinib Administered Orally With Multiple Doses Of Ketoconazole To Healthy Adult Subjects. |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | August 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: Bosutinib (SKI-606) |
- Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests. [ Time Frame: 5 weeks ]
- Blood samples [ Time Frame: 5 weeks ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
- 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.
- Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥ 50 kg.
- Healthy as determined by the investigator on the basis of screening evaluations.
Exclusion criteria:
- Family history QT prolongation, syncope, seizure, or unexplained cardiac related death.
- Presence or history of any disorder that may prevent the successful completion of the study.
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777530
Netherlands | |
Utrecht, Netherlands, 3584 |
Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
Responsible Party: | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
ClinicalTrials.gov Identifier: | NCT00777530 |
Other Study ID Numbers: |
3160A4-1114 |
First Posted: | October 22, 2008 Key Record Dates |
Last Update Posted: | October 23, 2008 |
Last Verified: | October 2008 |