Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects
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Purpose
The purpose of this study is to assess the pharmacokinetics of bosutinib and the safety and tolerability of bosutinib in healthy subjects and subjects with liver disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Leukemia, Myeloid, Chronic |
Drug: Bosutinib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of Bosutinib in Subjects With Chronic Hepatic Impairment and in Matched Healthy Adults |
- Blood samples [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
- Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests. [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 27 |
| Study Start Date: | October 2008 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: Bosutinib |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion criteria (for both study populations):
Men or women of nonchildbearing potential (WONCBP) aged 18 to 65 years inclusive at screening.
WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for more than 1 year (with follicle-stimulating hormone [FSH] level greater than or equal to 8 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue using it for 12 weeks after test article administration.
- Have a high probability for compliance with and completion of the study.
Exclusion criteria (for both study populations):
- History of clinically important cardiovascular disease.
- Family history of QT prolongation, syncope, seizure, or unexplained cardiac-related death.
- Presence or history of any disorder that may prevent the successful completion of the study.
Other inclusion and exclusion criteria apply.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| ClinicalTrials.gov Identifier: | NCT00759837 History of Changes |
| Other Study ID Numbers: | 3160A4-1111 |
| Study First Received: | September 23, 2008 |
| Last Updated: | July 15, 2009 |
| Health Authority: | Poland: Ministry of Health |
Additional relevant MeSH terms:
|
Breast Neoplasms Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Neoplasms by Histologic Type Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013