NCT00777530CompletedPhase 1
Ascending Single-Dose Of The Safety, Tolerability, And Pharmacokinetics Of Bosutinib Administered Orally With Multiple Doses Of Ketoconazole To Healthy Adult Subjects.
Wyeth is now a wholly owned subsidiary of Pfizer0 sites48 target enrollmentStarted: April 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Primary Endpoint
- Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Experimental
Intervention: Bosutinib (SKI-606) (Drug)
Outcomes
Primary Outcomes
Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests.
Time Frame: 5 weeks
Secondary Outcomes
- Blood samples(5 weeks)
Investigators
Similar Trials
Completed
Phase 1
Study of the Safety, Tolerability, and PK of PRA-027 Administered to Women of Nonchildbearing PotentialFibroidNCT00427544Wyeth is now a wholly owned subsidiary of Pfizer
Terminated
Phase 1
Study Evaluating HTC-867 in Healthy Young and Elderly SubjectsHealthy SubjectsNCT00827489Wyeth is now a wholly owned subsidiary of Pfizer72
Withdrawn
Phase 1
Study Evaluating Single Doses of GAP-134Healthy SubjectsNCT00820521Wyeth is now a wholly owned subsidiary of Pfizer
Terminated
Phase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2205 in Healthy Young Males and Females and Elderly Females and to Evaluate the Effect of Food on the Pharmacokinetics of a Single Dose of of ASP2205Healthy SubjectsPharmacokinetics of ASP2205NCT02314793Astellas Pharma Europe B.V.93
Completed
Phase 1
Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese FemalesUterine Leiomyomata (Fibroids)NCT00444704Wyeth is now a wholly owned subsidiary of Pfizer