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A Study to Determine the Safety and Efficacy of LX3305 in Subjects With Active Rheumatoid Arthritis

NCT01417052 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-08-02

No results posted yet for this study

Summary

The primary objective of this study is to determine the safety of LX3305 in a dose escalation compared with placebo over 12 weeks in subjects with active rheumatoid arthritis (RA).

Conditions

Interventions

DRUG

50 mg LX3305 QD

50 mg LX3305 once daily in capsule form

DRUG

100 mg LX3305 QD

100 mg LX3305 once daily in capsule form

DRUG

150 mg LX3305 QD

150 mg LX3305 once daily in capsule form

DRUG

200 mg LX3305 QD

200 mg LX3305 once daily in capsule form

DRUG

250 mg LX3305 QD

250 mg LX3305 once daily in capsule form

DRUG

300 mg LX3305 QD

300 mg LX3305 once daily in capsule form

DRUG

400 mg LX3305 QD

400 mg LX3305 once daily in capsule form

DRUG

250 mg LX3305 BID

250 mg LX3305 twice daily in capsule form

DRUG

500 mg LX3305 QD

500 mg LX3305 once daily in capsule form

DRUG

Placebo

Matching placebo dosing in capsule form

Sponsors & Collaborators

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Joel Freiman, MD, MPH · Lexicon Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01417052 on ClinicalTrials.gov