Pharmacokinetic VariablesPhase 1NCT00719693
Assessment of the Effect of Food on ABT-143 Bioavailability
A Phase 1 study testing ABT-143 ( rosuvastatin calcium and fenofibric acid ) and ABT-143 (rosuvastatin calcium and fenofibric acid ) in people with Pharmacokinetic Variables, run by AstraZeneca at 1 site in United States.
Trial summary
Single-dose, open-label, two-period crossover study of ABT-143 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic Variables
- What is being tested?
- ABT-143 ( rosuvastatin calcium and fenofibric acid ) and ABT-143 (rosuvastatin calcium and fenofibric acid )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Sep 2008
- 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
- 18-55 years of age (inclusive)
- BMI 19 to 29 inclusive
Who cannot join
- Asian ancestry
- Concurrent participation in another study
- Females pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 9242
Evansville, Indiana, 47710
About this study
Single-dose, open-label, two-period crossover study of ABT-143
- Conditions
- Pharmacokinetic Variables
- Being tested
- ABT-143 ( rosuvastatin calcium and fenofibric acid ), ABT-143 (rosuvastatin calcium and fenofibric acid )
- Keywords
- Food effect, phase I, adverse events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-143 ( rosuvastatin calcium and fenofibric acid )Drug
Also called ABT-143, fenofibric acid/rosuvastatin calcium
one dose under low-fat meal condition
ABT-143 (rosuvastatin calcium and fenofibric acid )Drug
one dose under fasting meal condition
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | ABT-143 under low-fat meal condition Receives: Drug: ABT-143 ( rosuvastatin calcium and fenofibric acid ) |
| B | Experimental | ABT-143 under fasting meal condition Receives: Drug: ABT-143 (rosuvastatin calcium and fenofibric acid ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Measured: 7 days
Secondary outcomes (1)
Adverse Events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetic VariablesStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Torbjörn Lundström, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719693
- Sponsor's protocol ID
- M10-442
- Status last verified
- Sep 2012
- First submitted
- 18 Jul 2008
- Last updated
- 28 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Food on ABT-143 Bioavailability
- ClinicalTrials.gov ID
- NCT00719693
- Acronym / sponsor ID
- M10-442
- Conditions
- Pharmacokinetic Variables
- Keywords
- Food effect, phase I, adverse events
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Sep 2008 (actual)
- First posted
- 22 Jul 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.
Single-dose, open-label, two-period crossover study of ABT-143
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ABT-143 ( rosuvastatin calcium and fenofibric acid )ABT-143 under low-fat meal condition |
| B | Experimental | Drug: ABT-143 (rosuvastatin calcium and fenofibric acid )ABT-143 under fasting meal condition |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-55 years of age (inclusive)
- BMI 19 to 29 inclusive
Key exclusion criteria (3 listed)
- Asian ancestry
- Concurrent participation in another study
- Females pregnant or breastfeeding
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 |
|---|---|---|
| ABT-143 ( rosuvastatin calcium and fenofibric acid )Also: ABT-143, fenofibric acid/rosuvastatin calciumone dose under low-fat meal condition | Drug | A |
| ABT-143 (rosuvastatin calcium and fenofibric acid )one dose under fasting meal condition | Drug | B |
Primary outcome
Pharmacokinetics
Time frame: 7 days
1 secondary outcome
Adverse Events
Time frame: 30 days
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 28 Sep 2012.
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.
Torbjörn Lundström, MD study director
AstraZeneca
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 ABT-143 ( rosuvastatin calcium and fenofibric acid ) and ABT-143 (rosuvastatin calcium and fenofibric acid ) in people with Pharmacokinetic Variables, 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 3 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 28 Sep 2012. 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?
Pharmacokinetics (time frame: 7 days). 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 28 Sep 2012.