HealthyPhase 1NCT00655746
The Effect of Omeprazole on the Pharmacokinetics of Dasatinib in Healthy Subjects
A Phase 1 study testing Dasatinib + Omeprazole in people with Healthy, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of omeprazole on the pharmacokinetics of dasatinib in healthy subjects and to assess the safety and tolerability of a single dose of dasatinib before and after 5 days of dosing with omeprazole in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dasatinib + Omeprazole
- 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
- Apr 2008to May 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects as determined by medical history, physical examination, ECGs, and clinical laboratory determinations
Who cannot join
- Women who are pregnant or breastfeeding
- Prior exposure to dasatinib
Trial locations and contacts
1 site in 1 country.
United States1 site
Bristol-Myers Squibb Clinical Pharmacology Unit
Hamilton, New Jersey, 08690
About this study
Official title: The Effect of Omeprazole on the Pharmacokinetics of Dasatinib (BMS-354825) in Healthy Subjects
The purpose of this study is to assess the effect of omeprazole on the pharmacokinetics of dasatinib in healthy subjects and to assess the safety and tolerability of a single dose of dasatinib before and after 5 days of dosing with omeprazole in healthy subjects
- Conditions
- Healthy
- Being tested
- Dasatinib + Omeprazole
- Keywords
- Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dasatinib + OmeprazoleDrug
Also called Sprycel
Tablet/Capsule, Oral, (Dasatinib 100 mg)/(Omeprazole 40 mg), once daily, 7 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Dasatinib + Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dasatinib Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax)
Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of dasatinib
Measured: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose
Dasatinib PK Parameter Time of Maximum Observed Plasma Concentration(Tmax)
Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Tmax=time of maximum observed plasma concentration
Measured: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose
Dasatinib PK Parameter: Plasma Half-Life (T-HALF)
Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=plasma half-life
Measured: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose
Dasatinib PK Parameter: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T])
area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])for dasatinib
Measured: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose
Dasatinib PK Parameters: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF])
Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time
Measured: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose
Secondary outcomes (1)
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations
An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Measured: At Informed Consent (within 21 days of Day 1) through Study Discharge (Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655746
- Sponsor's protocol ID
- CA180-249
- Status last verified
- Dec 2009
- First submitted
- 3 Apr 2008
- Last updated
- 15 Dec 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Omeprazole on the Pharmacokinetics of Dasatinib (BMS-354825) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00655746
- Acronym / sponsor ID
- CA180-249
- Conditions
- Healthy
- Keywords
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 10 Apr 2008 (estimated)
- Results
- Posted 31 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of omeprazole on the pharmacokinetics of dasatinib in healthy subjects and to assess the safety and tolerability of a single dose of dasatinib before and after 5 days of dosing with omeprazole in healthy subjects
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Dasatinib + Omeprazole |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects as determined by medical history, physical examination, ECGs, and clinical laboratory determinations
Key exclusion criteria (2 listed)
- Women who are pregnant or breastfeeding
- Prior exposure to dasatinib
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 |
|---|---|---|
| Dasatinib + OmeprazoleAlso: SprycelTablet/Capsule, Oral, (Dasatinib 100 mg)/(Omeprazole 40 mg), once daily, 7 days | Drug | 1 |
Primary outcome
Dasatinib Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose
Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of dasatinib
Dasatinib PK Parameter Time of Maximum Observed Plasma Concentration(Tmax)
Time frame: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose
Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Tmax=time of maximum observed plasma concentration
Dasatinib PK Parameter: Plasma Half-Life (T-HALF)
Time frame: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose
Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=plasma half-life
Dasatinib PK Parameter: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T])
Time frame: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose
area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])for dasatinib
Dasatinib PK Parameters: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF])
Time frame: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose
Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time
1 secondary outcome
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations
Time frame: At Informed Consent (within 21 days of Day 1) through Study Discharge (Day 7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 Dasatinib + Omeprazole in people with Healthy, run by Bristol-Myers Squibb 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 1 inclusion and 2 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 15 Dec 2009. 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?
Yes. Results are posted in the registry (first posted 31 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dasatinib Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) (time frame: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose). The study lists 5 primary outcomes in all. 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 15 Dec 2009.