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

Breast Cancer Clinical Trial

Official title:

Ascending Single-Dose Of The Safety, Tolerability, And Pharmacokinetics Of Bosutinib Administered Orally With Multiple Doses Of Ketoconazole To Healthy Adult Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777530
• Other study ID #: 3160A4-1114
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2008
• Last updated: October 22, 2008
• Start date: April 2008
• Est. completion date: August 2008

Study information

• Verified date: October 2008
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics CommitteeNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Breast Cancer
• Leukemia
• Tumors

Intervention

Drug:
• Bosutinib (SKI-606)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests.		5 weeks	Yes
Secondary	Blood samples		5 weeks	No