Drug Drug InteractionsPhase 1NCT01197781
Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy Volunteers
A Phase 1 study testing FOSTAMATIN and Verapamil in people with Drug Drug Interactions and Healthy Volunteers, run by AstraZeneca at 1 site in United States.
Trial summary
This Study evaluates the possible drug interaction between FosD and verapamil when taken together. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interactions, Healthy Volunteers
- What is being tested?
- FOSTAMATIN and Verapamil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Oct 2010
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 35 kg/m2, inclusive.
- Females must be of non-childbearing potential
Who cannot join
- History of clinically significant disease or disorder or presence of GI, hepatic or renal disease
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the drug
- Any clinically significant abnormalities in lab safety tests or vital signs as results as judged by the Investigator
- Use of prescription or over-the-counter drugs within 2 weeks of first administration of investigational product
- Current smokers or use of nicotine products within 1 month prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-Centre Study to Assess the Pharmacokinetics of R406 in Healthy Volunteers When Fostamatinib Disodium 150 mg is Administered Alone and in Combination With Verapamil
This Study evaluates the possible drug interaction between FosD and verapamil when taken together.
Read the detailed description
An Open-label, Single-Centre Study to Assess the Pharmacokinetics of R406 in Healthy Volunteers when Fostamatinib Disodium 150 mg is Administered Alone and in Combination with Verapamil.
- Conditions
- Drug Drug Interactions, Healthy Volunteers
- Being tested
- FOSTAMATIN, Verapamil
- Keywords
- Phase I, FosD, fostamatinib disodium, verapamil, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOSTAMATINDrug
Oral tablets - single dose
VerapamilDrug
Oral tablets - administered 3 times daily over 4 days
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Experimental | Not described Receives: Drug: FOSTAMATIN |
| Period 2 | Experimental | Not described Receives: Drug: FOSTAMATIN; Drug: Verapamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine plasma PK parameters of R406 when FosD is given in combination with verapamil (including but not limited to: AUC, tmax, Cmax and terminal elimination half life (t1/2)) of FosD.
Measured: Daily during Treatment Period 1 (FosD alone) and Treatment Period 2 (FosD plus verapamil) until 96 hours post each single dose of FosD
Secondary outcomes (1)
To investigate safety and tolerability of FosD when given in combination with verapamil: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.
Measured: Screening, throughout both treatment periods, and follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Drug InteractionsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Layton, MD, Study director, AstraZenecaCarlos Prendes, MD, Principal investigator, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197781
- Sponsor's protocol ID
- D4300C00011
- Status last verified
- Nov 2010
- First submitted
- 8 Sep 2010
- Last updated
- 23 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-Centre Study to Assess the Pharmacokinetics of R406 in Healthy Volunteers When Fostamatinib Disodium 150 mg is Administered Alone and in Combination With Verapamil
- ClinicalTrials.gov ID
- NCT01197781
- Acronym / sponsor ID
- D4300C00011
- Conditions
- Drug Drug Interactions, Healthy Volunteers
- Keywords
- Phase I, FosD, fostamatinib disodium, verapamil, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 9 Sep 2010 (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 Study evaluates the possible drug interaction between FosD and verapamil when taken together.
Detailed description
An Open-label, Single-Centre Study to Assess the Pharmacokinetics of R406 in Healthy Volunteers when Fostamatinib Disodium 150 mg is Administered Alone and in Combination with Verapamil.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Experimental | Drug: FOSTAMATIN |
| Period 2 | Experimental | Drug: FOSTAMATIN, Drug: Verapamil |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 35 kg/m2, inclusive.
- Females must be of non-childbearing potential
Key exclusion criteria (5 listed)
- History of clinically significant disease or disorder or presence of GI, hepatic or renal disease
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the drug
- Any clinically significant abnormalities in lab safety tests or vital signs as results as judged by the Investigator
- Use of prescription or over-the-counter drugs within 2 weeks of first administration of investigational product
- Current smokers or use of nicotine products within 1 month prior to enrollment
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 |
|---|---|---|
| FOSTAMATINOral tablets - single dose | Drug | Period 1, Period 2 |
| VerapamilOral tablets - administered 3 times daily over 4 days | Drug | Period 2 |
Primary outcome
To determine plasma PK parameters of R406 when FosD is given in combination with verapamil (including but not limited to: AUC, tmax, Cmax and terminal elimination half life (t1/2)) of FosD.
Time frame: Daily during Treatment Period 1 (FosD alone) and Treatment Period 2 (FosD plus verapamil) until 96 hours post each single dose of FosD
1 secondary outcome
To investigate safety and tolerability of FosD when given in combination with verapamil: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.
Time frame: Screening, throughout both treatment periods, and follow-up.
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 23 Nov 2010.
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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.
Mark Layton, MD study director
AstraZeneca
Carlos Prendes, MD principal investigator
Quintiles, Inc.
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 FOSTAMATIN and Verapamil in people with Drug Drug Interactions and Healthy Volunteers, run by AstraZeneca 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 2 inclusion and 5 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 23 Nov 2010. 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 determine plasma PK parameters of R406 when FosD is given in combination with verapamil (including but not limited to: AUC, tmax, Cmax and terminal elimination half life (t1/2)) of FosD. (time frame: Daily during Treatment Period 1 (FosD alone) and Treatment Period 2 (FosD plus verapamil) until 96 hours post each single dose of FosD). 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 23 Nov 2010.