A Non-randomized, Open-label Study to Investigate the Effects of Imatinib Mesylate on the Pharmacokinetics of Acetaminophen/Paracetamol in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

Novartis Pharmaceuticals1 site in 1 country12 target enrollmentNovember 2006

ConditionsChronic Myeloid Leukemia (CML)

InterventionsImatinib/Acetaminophen

DrugsImatinib/Acetaminophen

Overview

Phase: Phase 1
Intervention: Imatinib/Acetaminophen
Conditions: Chronic Myeloid Leukemia (CML)
Sponsor: Novartis Pharmaceuticals
Enrollment: 12
Locations: 1
Primary Endpoint: To investigate the effects of the co-administration of imatinib on the pharmacokinetics of acetaminophen / paracetamol
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A non-randomized, open-label study to investigate the effects of imatinib mesylate on the pharmacokinetics of acetaminophen/paracetamol in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP)

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

August 2008

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Drug-Drug interaction

Intervention: Imatinib/Acetaminophen

Outcomes

Primary Outcomes

To investigate the effects of the co-administration of imatinib on the pharmacokinetics of acetaminophen / paracetamol

Time Frame: Day 1, day 2 -7, Day 8

To investigate the pharmacokinetic characteristics of imatinib at steady state in CML-CP patients following 400 mg dosing co-administered with acetaminophen

Time Frame: Day 1, Day 2-7, Day 8