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Effect of Calcium on Tasigna Pharmacokinetics (PK) in Healthy Volunteers

NCT00732888 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2013-12-18

No results posted yet for this study

Summary

This research study is being conducted through the University of Pittsburgh Cancer Institute (UPCI). It will evaluate the concentrations of Tasigna®, an oral drug used to treat some types of cancer, in the blood of healthy volunteers when taken with and without Tums Ultra®, a calcium product often used in the treatment of upset stomach and as a calcium supplement.

Conditions

  • Healthy

Interventions

DRUG

Nilotinib Hydrochloride

Dosage form: capsules Dosage: 400 mg (2 x 200 mg capsule) Frequency \& duration: On an 18-day schedule, one dose administered once on day 1 and once on day 15 (2 doses total)

DIETARY_SUPPLEMENT

calcium carbonate

Dosage form: tablets Dosage: 4000 mg (4 x 1000 mg tablet) Frequency: On an 18-day schedule, once daily day 15 (for Arm 1); or once daily day 1 (for Arm 2)

Sponsors & Collaborators

Principal Investigators

  • Jan H. Beumer, PharmD, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-08-31
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00732888 on ClinicalTrials.gov