Healthy SubjectsPhase 1NCT00379860
Study Evaluation LXR-623 in Healthy Adults
A Phase 1 study testing LXR-623 in people with Healthy Subjects, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
To evaluate the safety and tolerability of multiple doses of LXR in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- LXR-623
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 2006to Jan 2007
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy adults.
- Liver function tests, triglycerideres, and creatinine must be below upper limit of normal at screening.
Who cannot join
- A history or active presence of clinically important medical disease.
- Any metal implants or devices.
- Claustrophobia.
About this study
Official title: A Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of LXR-623 Administered Orally to Healthy Subjects
To evaluate the safety and tolerability of multiple doses of LXR in healthy adults.
- Conditions
- Healthy Subjects
- Being tested
- LXR-623
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LXR-623Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety is the primary outcome.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startOct 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Single group
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379860
- Sponsor's protocol ID
- 3201A1-101
- Status last verified
- Mar 2007
- First submitted
- 21 Sep 2006
- Last updated
- 9 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of LXR-623 Administered Orally to Healthy Subjects
- ClinicalTrials.gov ID
- NCT00379860
- Acronym / sponsor ID
- 3201A1-101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Jan 2007
- First posted
- 25 Sep 2006 (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 the safety and tolerability of multiple doses of LXR in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Generally healthy adults.
- Liver function tests, triglycerideres, and creatinine must be below upper limit of normal at screening.
Key exclusion criteria (3 listed)
- A history or active presence of clinically important medical disease.
- Any metal implants or devices.
- Claustrophobia.
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 |
|---|---|---|
| LXR-623 | Drug | – |
Primary outcome
Safety is the primary outcome.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2007.
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Healthy Participants
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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LXR-623 in people with Healthy Subjects, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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: stopped early, as of the sponsor's last update on 9 Mar 2007. 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 was stopped early. Results are not available in the source record.
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?
Safety is the primary outcome.. 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 9 Mar 2007.