HealthyPhase 1NCT00732888
Effect of Calcium on Tasigna Pharmacokinetics (PK) in Healthy Volunteers
A Phase 1 study testing Nilotinib Hydrochloride and calcium carbonate in people with Healthy, run by Jan Beumer at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nilotinib Hydrochloride and calcium carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Sep 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men or women 18 years of age or older. Healthy subjects are defined as individuals who are free from clinically significant illness or disease (such as coronary arterial disease, chronic heart failure, bleeding disorder, hypertension, chronic renal failure etc.) as determined by their medical history, physical examination, and laboratory studies.
- Body Mass Index (BMI) < 31 kg/m2 (weight/height2).
- Female patients of childbearing potential must have negative pregnancy test within 14 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
- Written, voluntary informed consent.
Who cannot join
- Abnormal marrow function as defined by leucocyte, neutrophil, or platelet counts outside of normal limits.
- Any evidence of renal dysfunction (proteinuria; serum creatinine > upper limit of normal; or if serum creatinine > upper limit of normal, a calculated creatinine clearance < 60 mL/min/1.73 m2).
- Impaired hepatic function (liver enzymes greater than the upper limit of normal or bilirubin outside the normal range).
- QTcF > 450 msec on screening ECG (using the QTcF formula).
- Patient with electrolyte abnormality (e.g., hypokalemia, hypomagnesemia, hypophosphatemia, hyperkalemia, hypocalcemia, hyponatremia).
- Taking any medications (including over the counter products), herbal products, mineral supplements or vitamins (other than a daily multivitamin preparation), other than contraceptives (for women), within 2 weeks of start of the study. All forms of contraceptive medication are permissible for this study and would not result in a female's exclusion from participation. Patients who take medications on a chronic basis, such as antihypertensive medications or thyroid replacement therapy, etc. are not eligible for the study.
- Subjects has received any other investigational agents within 28 days of first day of study drug dosing.
- Female subjects who are pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Cancer Institute / Clinical and Translational Research Center (Hillman Cancer Center and Montefiore University Hospital locations)
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Effect of Calcium Supplements on Nilotinib Hydrochloride Pharmacokinetics in Healthy Volunteers (CAMN107DUS10T) (UPCI 08-077)
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.
Read the detailed description
This is an open-label, single-institution, randomized cross-over, fixed-schedule investigation of the effects of calcium carbonate on the pharmacokinetics (PK) of Tasigna® in healthy volunteers. Healthy volunteers will be recruited to participate in this study such that twelve subjects (6 men / 6 women) will complete the study at UPCI. Subjects will be compensated for participation.
Half of the subjects will receive Tasigna® alone on Day 1 and Tasigna® and calcium carbonate on Day 15, and the other half will receive Tasigna® and calcium carbonate on Day 1 and Tasigna® alone on Day 15, determined by randomization of subjects receiving either the combination or Tasigna® alone during the first visit. Doses will be 400 mg Tasigna® (2 x 200 mg tablets) and 4000 mg calcium carbonate (4 x Tums Ultra 1000® chewable tablets, equivalent to 4000 mg calcium carbonate or 1600 mg calcium).
Multiple PK blood samples will be taken from Days 1-4 and Days 15-18. Tasigna® PK will be assessed after oral administration of 400 mg Tasigna® alone, and after oral administration of 400 mg Tasigna® with concomitant administration of 4000 mg calcium carbonate. Two two-day/one-night inpatient stays and four brief outpatient visits are required to accommodate all study procedures.
- Conditions
- Healthy
- Being tested
- Nilotinib Hydrochloride, calcium carbonate
- Keywords
- Pharmacokinetics, Healthy volunteers, No condition, Pharmacokinetics study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nilotinib HydrochlorideDrug
Also called Tasigna®, AMN107
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)
calcium carbonateDietary supplement
Also called Tums Ultra 1000®
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)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | On an 18-day schedule, calcium supplement (Tums Ultra 1000®) once daily on day 15; and Tasigna® once daily on days 1 and 15 (i.e., Tasigna® alone on day 1, and combination of Tasigna® and calcium supplement on day 15). Receives: Drug: Nilotinib Hydrochloride; Dietary Supplement: calcium carbonate |
| 2 | Other | On an 18-day schedule, calcium supplement (Tums Ultra 1000®) once daily on day 1; and Tasigna® once daily on days 1 and 15 (i.e., combination of Tasigna® and calcium supplement on day 1, Tasigna® alone on day 15). Receives: Drug: Nilotinib Hydrochloride; Dietary Supplement: calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the effect of administration of a calcium salt (calcium carbonate) on the PK (in particular the area under the nilotinib plasma concentration versus time curve) of nilotinib (Tasigna® ) in healthy volunteers.
Measured: PK blood samples are drawn from each subject at time 0 (before each dose of Tasigna®), and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, and 72 hrs after adminstration of Tasigna®.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Beumer
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor-investigator, Jan Beumer, University of Pittsburgh
- Investigators
- Jan H. Beumer, PharmD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732888
- Sponsor's protocol ID
- 08-077
- Other IDs
- CAMN107DUS10T, UPCI 08-077
- Status last verified
- Dec 2013
- First submitted
- 7 Aug 2008
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calcium Supplements on Nilotinib Hydrochloride Pharmacokinetics in Healthy Volunteers (CAMN107DUS10T) (UPCI 08-077)
- ClinicalTrials.gov ID
- NCT00732888
- Acronym / sponsor ID
- 08-077
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Healthy volunteers, No condition, Pharmacokinetics study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Jan BeumerUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Nov 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 12 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, single-institution, randomized cross-over, fixed-schedule investigation of the effects of calcium carbonate on the pharmacokinetics (PK) of Tasigna® in healthy volunteers. Healthy volunteers will be recruited to participate in this study such that twelve subjects (6 men / 6 women) will complete the study at UPCI. Subjects will be compensated for participation.
Half of the subjects will receive Tasigna® alone on Day 1 and Tasigna® and calcium carbonate on Day 15, and the other half will receive Tasigna® and calcium carbonate on Day 1 and Tasigna® alone on Day 15, determined by randomization of subjects receiving either the combination or Tasigna® alone during the first visit. Doses will be 400 mg Tasigna® (2 x 200 mg tablets) and 4000 mg calcium carbonate (4 x Tums Ultra 1000® chewable tablets, equivalent to 4000 mg calcium carbonate or 1600 mg calcium).
Multiple PK blood samples will be taken from Days 1-4 and Days 15-18. Tasigna® PK will be assessed after oral administration of 400 mg Tasigna® alone, and after oral administration of 400 mg Tasigna® with concomitant administration of 4000 mg calcium carbonate. Two two-day/one-night inpatient stays and four brief outpatient visits are required to accommodate all study procedures.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Nilotinib Hydrochloride, Dietary Supplement: calcium carbonateOn an 18-day schedule, calcium supplement (Tums Ultra 1000®) once daily on day 15; and Tasigna® once daily on days 1 and 15 (i.e., Tasigna® alone on day 1, and combination of Tasigna® and calcium supplement on day 15). |
| 2 | Other | Drug: Nilotinib Hydrochloride, Dietary Supplement: calcium carbonateOn an 18-day schedule, calcium supplement (Tums Ultra 1000®) once daily on day 1; and Tasigna® once daily on days 1 and 15 (i.e., combination of Tasigna® and calcium supplement on day 1, Tasigna® alone on day 15). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy men or women 18 years of age or older. Healthy subjects are defined as individuals who are free from clinically significant illness or disease (such as coronary arterial disease, chronic heart failure, bleeding disorder, hypertension, chronic renal failure etc.) as determined by their medical history, physical examination, and laboratory studies.
- Body Mass Index (BMI) < 31 kg/m2 (weight/height2).
- Female patients of childbearing potential must have negative pregnancy test within 14 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
- Written, voluntary informed consent.
Key exclusion criteria (8 listed)
- Abnormal marrow function as defined by leucocyte, neutrophil, or platelet counts outside of normal limits.
- Any evidence of renal dysfunction (proteinuria; serum creatinine > upper limit of normal; or if serum creatinine > upper limit of normal, a calculated creatinine clearance < 60 mL/min/1.73 m2).
- Impaired hepatic function (liver enzymes greater than the upper limit of normal or bilirubin outside the normal range).
- QTcF > 450 msec on screening ECG (using the QTcF formula).
- Patient with electrolyte abnormality (e.g., hypokalemia, hypomagnesemia, hypophosphatemia, hyperkalemia, hypocalcemia, hyponatremia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nilotinib HydrochlorideAlso: Tasigna®, AMN107Dosage 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) | Drug | 1, 2 |
| calcium carbonateAlso: Tums Ultra 1000®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) | Dietary supplement | 1, 2 |
Primary outcome
To define the effect of administration of a calcium salt (calcium carbonate) on the PK (in particular the area under the nilotinib plasma concentration versus time curve) of nilotinib (Tasigna® ) in healthy volunteers.
Time frame: PK blood samples are drawn from each subject at time 0 (before each dose of Tasigna®), and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, and 72 hrs after adminstration of Tasigna®.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan H. Beumer, PharmD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nilotinib Hydrochloride and calcium carbonate in people with Healthy, run by Jan Beumer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define the effect of administration of a calcium salt (calcium carbonate) on the PK (in particular the area under the nilotinib plasma concentration versus time curve) of nilotinib (Tasigna® ) in healthy volunteers. (time frame: PK blood samples are drawn from each subject at time 0 (before each dose of Tasigna®), and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, and 72 hrs after adminstration of Tasigna®.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.