Study Evaluating The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib In Healthy Subjects

NCT ID: NCT00952913

Last Updated: 2011-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-10-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Bosutinib

Group Type EXPERIMENTAL

Bosutinib

Intervention Type DRUG

4 x 100-mg oral tablets, single dose

2

bosutinib + lansoprazole

Group Type EXPERIMENTAL

Bosutinib

Intervention Type DRUG

4 x 100-mg oral tablets, single dose

Lansoprazole

Intervention Type DRUG

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

Interventions

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Bosutinib

4 x 100-mg oral tablets, single dose

Intervention Type DRUG

Bosutinib

4 x 100-mg oral tablets, single dose

Intervention Type DRUG

Lansoprazole

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

Intervention Type DRUG

Other Intervention Names

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SKI-606 SKI-606 Prevacid

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Any cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Miami, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23839484 (View on PubMed)

Related Links

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Other Identifiers

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B1871002

Identifier Type: -

Identifier Source: secondary_id

3160A4-1108

Identifier Type: -

Identifier Source: org_study_id

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