Adverse EventsPhase 1NCT00681395
Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium
A Phase 1 study testing ABT-143, ABT-335 and Rosuvastatin in people with Adverse Events and Pharmacokinetic, run by AstraZeneca at 1 site in United States.
Trial summary
To evaluate safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Events, Pharmacokinetic
- What is being tested?
- ABT-143, ABT-335 and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Aug 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
- General good health
- BMI 19 to 29
Who cannot join
- Currently enrolled in another study
- Females who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 8089
Orlando, Florida, 32809
About this study
To evaluate safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.
- Conditions
- Adverse Events, Pharmacokinetic
- Being tested
- ABT-143, ABT-335, Rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-143Drug
once daily for 6 days
ABT-335Drug
once daily for six days
RosuvastatinDrug
Once daily for 6 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ABT-143 capsules 20/135 mg Receives: Drug: ABT-143 |
| 2 | Active comparator | ABT-335 135mg and rosuvastatin 20mg Receives: Drug: ABT-335; Drug: Rosuvastatin |
| 3 | Experimental | ABT-143 capsules 5/45mg Receives: Drug: ABT-143 |
| 4 | Active comparator | ABT-335 45mg and rosuvastatin 5mg Receives: Drug: ABT-335; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event and safety laboratory assessments
Measured: 7 days
Pharmacokinetic parameters
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse EventsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 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
- NCT00681395
- Sponsor's protocol ID
- M10-360
- Status last verified
- Sep 2012
- First submitted
- 19 May 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
- Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium
- ClinicalTrials.gov ID
- NCT00681395
- Acronym / sponsor ID
- M10-360
- Conditions
- Adverse Events, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Aug 2008 (actual)
- First posted
- 21 May 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.
To evaluate safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ABT-143ABT-143 capsules 20/135 mg |
| 2 | Active comparator | Drug: ABT-335, Drug: RosuvastatinABT-335 135mg and rosuvastatin 20mg |
| 3 | Experimental | Drug: ABT-143ABT-143 capsules 5/45mg |
| 4 | Active comparator | Drug: ABT-335, Drug: RosuvastatinABT-335 45mg and rosuvastatin 5mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- General good health
- BMI 19 to 29
Key exclusion criteria (2 listed)
- Currently enrolled in another study
- Females who are 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-143once daily for 6 days | Drug | 1, 3 |
| ABT-335once daily for six days | Drug | 2, 4 |
| RosuvastatinOnce daily for 6 days | Drug | 2, 4 |
Primary outcome
Adverse event and safety laboratory assessments
Time frame: 7 days
Pharmacokinetic parameters
Time frame: 7 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.
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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.
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, ABT-335 and Rosuvastatin in people with Adverse Events and Pharmacokinetic, 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 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 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?
Adverse event and safety laboratory assessments (time frame: 7 days). The study lists 2 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 28 Sep 2012.