Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions

NCT01080365 | Completed Phase 1

• 2 other identifiers: 3160A4-1120B1871016
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Study comparing 2 formulations of bosutinib in healthy subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics, as measured by Cmax, AUC, tmax, t1/2

  2 weeks

Study Arms (2)

1

EXPERIMENTAL

Commercial Tablet

Drug: SKI-606 (Bosutinib)

2

EXPERIMENTAL

Clinical Tablet

Drug: SKI-606 (Bosutinib)

Interventions

SKI-606 (Bosutinib) DRUG

500 mg commercial formulation film coated tablet, administered once daily

Also known as: Bosutinib

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women of nonchildbearing potential age 18 to 50 years

You may not qualify if:

• Any clinically significant medical condition

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Tacoma, Washington, 98418, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

bosutinib

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 4, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 6, 2010

Record last verified: 2010-09

Locations

US (1)