HealthyPhase 1NCT00427505
Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam
A Phase 1 study testing Deferasirox in people with Healthy, run by Novartis.
Trial summary
This is a study to investigate the pharmacokinetics of deferasirox Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Deferasirox
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to not given
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good health
- No evidence of iron deficiency
- Weight between 50 and 100 kg
- Body Mass Index between 19 and 29 kg/m2
Who cannot join
- Use of certain drugs, herbal remedies or nutrients
- Other protocol-defined inclusion/exclusion criteria may apply
About this study
Official title: An Open-label, One-sequence Cross-over Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam in Healthy Volunteers
This is a study to investigate the pharmacokinetics of deferasirox
- Conditions
- Healthy
- Being tested
- Deferasirox
- Keywords
- Interaction, healthy volunteers, deferasirox, midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeferasiroxDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of deferasirox on the pharmacokinetics of midazolam
Secondary outcomes (1)
Safety assessed by adverse events (AEs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startJul 2006
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427505
- Sponsor's protocol ID
- CICL670A2126
- Status last verified
- Nov 2009
- First submitted
- 25 Jan 2007
- Last updated
- 19 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, One-sequence Cross-over Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00427505
- Acronym / sponsor ID
- CICL670A2126
- Conditions
- Healthy
- Keywords
- Interaction, healthy volunteers, deferasirox, midazolam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- First posted
- 29 Jan 2007 (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 is a study to investigate the pharmacokinetics of deferasirox
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Good health
- No evidence of iron deficiency
- Weight between 50 and 100 kg
- Body Mass Index between 19 and 29 kg/m2
Key exclusion criteria (2 listed)
- Use of certain drugs, herbal remedies or nutrients
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| Deferasirox | Drug | – |
Primary outcome
To assess the effect of deferasirox on the pharmacokinetics of midazolam
1 secondary outcome
Safety assessed by adverse events (AEs)
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 19 Nov 2009.
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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.
Novartis study chair
Novartis
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deferasirox in people with Healthy, run by Novartis.
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 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 19 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
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 assess the effect of deferasirox on the pharmacokinetics of midazolam. 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 19 Nov 2009.