NCT01417052

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

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects With Active Rheumatoid Arthritis (RA)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-08-16
• Last updated: 2012-08-02

Locations

1 site across 1 country: United States