Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects

Wyeth

Status and phase: Completed; Phase 1

Conditions: Tumors; Breast Cancer; Leukemia

Treatments: Drug: Bosutinib (SKI-606)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00777530

3160A4-1114

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

48 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Bosutinib (SKI-606)