Drug Interaction Study Between Bosutinib And Dabigatran

NCT02102633 | Completed Phase 1

• 1 other identifier: B1871043
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the effect of a single oral dose of bosutinib on the single dose pharmacokinetics of dabigatran, a p-glycoprotein substrate, in healthy subjects.

Conditions

Healthy

Keywords

bosutinib; dabigatran; drug interaction; p-glycoprotein; pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  48 hours

• Maximum Observed Plasma Concentration (Cmax)

  Maximum Observed Plasma Concentration

  48 hours

Secondary Outcomes (5)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  48 hours

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  48 hours

• Plasma Decay Half-Life (t1/2)

  48 hours

• Apparent Oral Clearance (CL/F)

  48 hours

• Apparent Volume of Distribution (Vz/F)

  48 hours

Study Arms (2)

Dabigatran

EXPERIMENTAL

Dabigatran 150 mg orally

Drug: Dabigatran

Dabigatran + Bosutinib

EXPERIMENTAL

Dabigatran 150 mg co-administered with Bosutinib 500 mg orally

Drug: Bosutinib; Drug: Dabigatran

Interventions

Dabigatran DRUG

Dabigatran 150 mg orally

Dabigatran

Bosutinib DRUG

Bosutinib 500 mg orally

Dabigatran + Bosutinib

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects between 21 to 55 years old and BMI between 17.5 and 30.5 kg/m2.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Risks of bleeding including prior personal or familiar history of abnormal bleeding, hereditary or acquired coagulation or platelet disorder or abnormal coagulation test (PT/INR or PTT/aPTT greater than upper limit of normal) result at screening.
• Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

DeLand, Florida, 32720, United States

Location

Related Publications (1)

• Hsyu PH, Pignataro DS, Matschke K. Effect of bosutinib on the absorption of dabigatran etexilate mesylate, a P-glycoprotein substrate, in healthy subjects. Eur J Clin Pharmacol. 2017 Jan;73(1):57-63. doi: 10.1007/s00228-016-2115-0. Epub 2016 Oct 7.

  PMID: 27717999 DERIVED

Related Links

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

MeSH Terms

Interventions

Dabigatran; bosutinib

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 3, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

US (1)