NCT00952913

Brief Summary

The purpose of this study is to see if there is an effect on the pharmacokinetics of bosutinib when administered with lansoprazole.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

April 19, 2011

Status Verified

April 1, 2011

Enrollment Period

2 months

First QC Date

August 3, 2009

Last Update Submit

April 18, 2011

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

    1 month

Study Arms (2)

1

EXPERIMENTAL

Bosutinib

Drug: Bosutinib

2

EXPERIMENTAL

bosutinib + lansoprazole

Drug: BosutinibDrug: Lansoprazole

Interventions

BosutinibDRUG

4 x 100-mg oral tablets, single dose

Also known as: SKI-606
1
LansoprazoleDRUG

2 x 30-mg oral tablets, single daily doses for 2 days

Also known as: Prevacid
2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women of nonchildbearing potential, between the ages of 18 to 50 years old.

You may not qualify if:

  • Any cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Miami, Florida, 33126, United States

Location

Related Publications (1)

  • Abbas R, Leister C, Sonnichsen D. A clinical study to examine the potential effect of lansoprazole on the pharmacokinetics of bosutinib when administered concomitantly to healthy subjects. Clin Drug Investig. 2013 Aug;33(8):589-95. doi: 10.1007/s40261-013-0103-z.

    PMID: 23839484DERIVED

Related Links

MeSH Terms

Interventions

bosutinibLansoprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 6, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

April 19, 2011

Record last verified: 2011-04

Locations

US(1)