Conditions: Ulcerative Colitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 59
Healthy volunteers: no

Brief summary:
This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and preliminary effectiveness of two blinded dose levels of telotristat etiprate (LX1606) in participants with acute, mild to moderate ulcerative colitis on 5-aminosalicylic acid/mesalamine therapy.

Detailed description:

Arms:
arm 1: 500 mg telotristat etiprate (LX1606) administered orally once daily (QD). arm 2: 500 mg telotristat etiprate (LX1606) administered orally three times daily (TID). arm 3: Matching placebo administered orally.

Interventions: intervention 1: Telotristat Etiprate intervention 2: Placebo
Intervention descriptions: intervention 1: 500 mg telotristat etiprate (LX1606) administered orally. intervention 2: Matching placebo administered orally.

Protocol document: