Rheumatoid ArthritisPhase 1NCT00847886
Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis
A Phase 1 study testing LX3305 and Methotrexate in people with Rheumatoid Arthritis, run by Lexicon Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the effect of LX3305 on methotrexate (MTX) pharmacokinetics and to evaluate the safety and tolerability of LX3305 given over 14 days in subjects with stable rheumatoid arthritis that are receiving stable doses of MTX. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- LX3305 and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Mar 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years old
- Must be willing to practice 2 adequate methods of contraception for the duration of the study
- Rheumatoid arthritis present for at least 3 months; functional class I, II, or III as defined by ACR criteria
- Treatment with methotrexate (7.5 to 25 mg per week) for at least the last 3 months, and currently receiving stable dose methotrexate for at least one month prior to the start of the study
- Ability to provide written informed consent
Who cannot join
- Women who are pregnant or nursing
- History of other current inflammatory arthritis
- History of opportunistic infection
- History of recurrent infections or current infection 2 weeks prior to start of study
- Presence of significant, uncontrolled medical problems
- Treatment with any disease-modifying anti-rheumatoid drugs other than methotrexate within 4 weeks prior to start of study
Show all 9Show fewer
- Use of chondroitin sulfate, glucosamine sulfate, minocycline, or matrix metalloproteinase inhibitors, H-2 blockers, proton pump inhibitors, or misoprostol within 4 weeks prior to study start
- Receipt of live vaccine within 8 weeks prior to study start
- Rheumatoid arthritis, functional class IV as defined by ACR criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Metroplex Clinical Research Center
Dallas, Texas, 75235
About this study
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis
The purpose of the study is to evaluate the effect of LX3305 on methotrexate (MTX) pharmacokinetics and to evaluate the safety and tolerability of LX3305 given over 14 days in subjects with stable rheumatoid arthritis that are receiving stable doses of MTX.
- Conditions
- Rheumatoid Arthritis
- Being tested
- LX3305, LX3305 Placebo, Methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LX3305Drug
Daily oral intake of LX3305 for 14 days.
LX3305 PlaceboDrug
Matching placebo dosing with daily oral intake for 14 days.
MethotrexateDrug
Once weekly stable-dose methotrexate.
| Study group | Role | What they receive |
|---|---|---|
| LX3305 | Experimental | Daily oral intake of LX3305 for 14 days. Receives: Drug: LX3305; Drug: Methotrexate |
| LX3305 Placebo | Placebo comparator | Matching placebo dosing with daily oral intake for 14 days. Receives: Drug: LX3305 Placebo; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methotrexate Maximum Plasma Concentration
Measured: Day 15
Time to Reach Maximum Plasma Concentration of Methotrexate
Measured: Day 15
Half-life of Methotrexate in Plasma
Measured: Day 15
Amount of Methotrexate Excreted in the Urine
Measured: Day 15
7-Hydroxymethotrexate (7-OH-MTX) Maximum Plasma Concentration
7-OH-MTX is the primary metabolite of methotrexate.
Measured: Day 15
Time to Reach Maximum Plasma Concentration of 7-OH-MTX
Measured: Day 15
Amount of 7-OH-MTX Excreted in the Urine
Measured: Day 15
Secondary outcomes (4)
Maximum Plasma Concentration of LX3305 in the Presence of MTX
Measured: Day 15
Time to Maximum Plasma Concentration of LX3305 in the Presence of MTX
Measured: Day 15
Half-life of LX3305 in Plasma in the Presence of MTX
Measured: Day 15
Percentage of Change From Baseline in Absolute Total Lymphocyte Count at Day 15
Baseline was defined as pre-dose on Day 1.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip M. Brown, MD, JD, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847886
- Sponsor's protocol ID
- Protocol LX3305.1-104-DDI
- Other IDs
- LX3305.104, LX2931
- Status last verified
- Jun 2010
- First submitted
- 17 Feb 2009
- Last updated
- 3 Jun 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00847886
- Acronym / sponsor ID
- Protocol LX3305.1-104-DDI
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Posted 3 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the effect of LX3305 on methotrexate (MTX) pharmacokinetics and to evaluate the safety and tolerability of LX3305 given over 14 days in subjects with stable rheumatoid arthritis that are receiving stable doses of MTX.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LX3305 | Experimental | Drug: LX3305, Drug: MethotrexateDaily oral intake of LX3305 for 14 days. |
| LX3305 Placebo | Placebo comparator | Drug: LX3305 Placebo, Drug: MethotrexateMatching placebo dosing with daily oral intake for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females ≥ 18 years old
- Must be willing to practice 2 adequate methods of contraception for the duration of the study
- Rheumatoid arthritis present for at least 3 months; functional class I, II, or III as defined by ACR criteria
- Treatment with methotrexate (7.5 to 25 mg per week) for at least the last 3 months, and currently receiving stable dose methotrexate for at least one month prior to the start of the study
- Ability to provide written informed consent
Key exclusion criteria (9 listed)
- Women who are pregnant or nursing
- History of other current inflammatory arthritis
- History of opportunistic infection
- History of recurrent infections or current infection 2 weeks prior to start of study
- Presence of significant, uncontrolled medical problems
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 |
|---|---|---|
| LX3305Daily oral intake of LX3305 for 14 days. | Drug | LX3305 |
| LX3305 PlaceboMatching placebo dosing with daily oral intake for 14 days. | Drug | LX3305 Placebo |
| MethotrexateOnce weekly stable-dose methotrexate. | Drug | LX3305, LX3305 Placebo |
Primary outcome
Methotrexate Maximum Plasma Concentration
Time frame: Day 15
Time to Reach Maximum Plasma Concentration of Methotrexate
Time frame: Day 15
Half-life of Methotrexate in Plasma
Time frame: Day 15
Amount of Methotrexate Excreted in the Urine
Time frame: Day 15
7-Hydroxymethotrexate (7-OH-MTX) Maximum Plasma Concentration
Time frame: Day 15
7-OH-MTX is the primary metabolite of methotrexate.
Time to Reach Maximum Plasma Concentration of 7-OH-MTX
Time frame: Day 15
Amount of 7-OH-MTX Excreted in the Urine
Time frame: Day 15
4 secondary outcomes
Maximum Plasma Concentration of LX3305 in the Presence of MTX
Time frame: Day 15
Time to Maximum Plasma Concentration of LX3305 in the Presence of MTX
Time frame: Day 15
Half-life of LX3305 in Plasma in the Presence of MTX
Time frame: Day 15
Percentage of Change From Baseline in Absolute Total Lymphocyte Count at Day 15
Time frame: Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Philip M. Brown, MD, JD study director
Lexicon Pharmaceuticals, Inc.
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 LX3305 and Methotrexate in people with Rheumatoid Arthritis, run by Lexicon Pharmaceuticals 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 5 inclusion and 9 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 3 Jun 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 3 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Methotrexate Maximum Plasma Concentration (time frame: Day 15). The study lists 7 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 3 Jun 2010.