PharmacokineticsPhase 1NCT00681525
A Multiple-Dose Pharmacokinetic Interaction Study Between ABT-335, Atorvastatin and Ezetimibe
A Phase 1 study testing ABT-335, Atorvastatin and Ezetimibe in people with Pharmacokinetics, run by Abbott at 1 site in United States.
Trial summary
The objective of this study is to evaluate the potential PK interaction between ABT-335, atorvastatin 80 mg and ezetimibe 10 mg when administered concurrently. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- ABT-335, Atorvastatin and Ezetimibe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jun 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
- Healthy male or female subjects
Who cannot join
- Clinically significant diseases or disorders
- Positive screens for drug and alcohol
- Pregnant or breast-feeding females
- Any history of surgery(ies) that might interfere with the gastrointestinal motility, pH or absorption
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 8087
Gainesville, Florida, 32608
About this study
The objective of this study is to evaluate the potential PK interaction between ABT-335, atorvastatin 80 mg and ezetimibe 10 mg when administered concurrently.
- Conditions
- Pharmacokinetics
- Being tested
- ABT-335, Atorvastatin, Ezetimibe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-335Drug
Also called fenofibric acid
One ABT-335 135 mg capsule QD for 10 days
AtorvastatinDrug
Also called atovastatin
One 80 mg tablet of atorvastatin QD for 10 days
EzetimibeDrug
One ezetimibe 10 mg tablet QD for 10 days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | ABT-335 135 mg Receives: Drug: ABT-335 |
| B | Experimental | Atorvastatin 80 mg and Ezetimibe 10 mg Receives: Drug: Atorvastatin; Drug: Ezetimibe |
| C | Experimental | ABT-335 135 mg, Atorvastatin 80 mg and Ezetimibe 10 mg Receives: Drug: ABT-335; Drug: Atorvastatin; Drug: Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK interaction
Measured: Study duration approximately 62 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 startApr 2008
- Primary completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681525
- Sponsor's protocol ID
- M10-367
- Status last verified
- Sep 2010
- First submitted
- 19 May 2008
- Last updated
- 19 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose Pharmacokinetic Interaction Study Between ABT-335, Atorvastatin and Ezetimibe
- ClinicalTrials.gov ID
- NCT00681525
- Acronym / sponsor ID
- M10-367
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 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.
The objective of this study is to evaluate the potential PK interaction between ABT-335, atorvastatin 80 mg and ezetimibe 10 mg when administered concurrently.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ABT-335ABT-335 135 mg |
| B | Experimental | Drug: Atorvastatin, Drug: EzetimibeAtorvastatin 80 mg and Ezetimibe 10 mg |
| C | Experimental | Drug: ABT-335, Drug: Atorvastatin, Drug: EzetimibeABT-335 135 mg, Atorvastatin 80 mg and Ezetimibe 10 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male or female subjects
Key exclusion criteria (4 listed)
- Clinically significant diseases or disorders
- Positive screens for drug and alcohol
- Pregnant or breast-feeding females
- Any history of surgery(ies) that might interfere with the gastrointestinal motility, pH or absorption
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-335Also: fenofibric acidOne ABT-335 135 mg capsule QD for 10 days | Drug | A, C |
| AtorvastatinAlso: atovastatinOne 80 mg tablet of atorvastatin QD for 10 days | Drug | B, C |
| EzetimibeOne ezetimibe 10 mg tablet QD for 10 days | Drug | B, C |
Primary outcome
PK interaction
Time frame: Study duration approximately 62 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 19 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
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-335, Atorvastatin and Ezetimibe in people with Pharmacokinetics, run by Abbott 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 4 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 Oct 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?
PK interaction (time frame: Study duration approximately 62 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 19 Oct 2010.