Phase 1
Completed N=16
Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00847886 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2010
Primary outcomePrimary: Methotrexate Maximum Plasma Concentration — 215; 177 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Methotrexate Maximum Plasma Concentration |
215; 177 | — |
| PRIMARY Time to Reach Maximum Plasma Concentration of Methotrexate |
0.98; 1.25 | — |
| PRIMARY Half-life of Methotrexate in Plasma |
3.80; 3.80 | — |
| PRIMARY Amount of Methotrexate Excreted in the Urine |
3861; 4022 | — |
| PRIMARY 7-Hydroxymethotrexate (7-OH-MTX) Maximum Plasma Concentration |
25.5; 25.5 | — |
| PRIMARY Time to Reach Maximum Plasma Concentration of 7-OH-MTX |
6.01; 8.00 | — |
| PRIMARY Amount of 7-OH-MTX Excreted in the Urine |
285; 281 | — |
| SECONDARY Maximum Plasma Concentration of LX3305 in the Presence of MTX |
588 | — |
| SECONDARY Time to Maximum Plasma Concentration of LX3305 in the Presence of MTX |
2.25 | — |
| SECONDARY Half-life of LX3305 in Plasma in the Presence of MTX |
5.89 | — |
| SECONDARY Percentage of Change From Baseline in Absolute Total Lymphocyte Count at Day 15 |
-14.049; -6.152 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00847886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.