Clinical trial NCT00628433 (phase 1/phase 2, status: completed)
Conditions: ulcerative colitis
ICD codes: K51.80, K51.813, K51.814, K51.90, K51.913, K51.914, K51.811
Drugs: placebo, he3286
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, C[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@@]2(O)C#C)[C@@H](O)C=C1C[C@@H](O)CC[C@]31C
Eligibility criteria:

        Inclusion Criteria:

          -  18-65 years of age

          -  Diagnosed (> 6 weeks) or recently relapsed active mild-to-moderate ulcerative colitis
             based on colonoscopy or flexible sigmoidoscopy

          -  Mayo Scoring System for Assessment of Ulcerative Colitis Activity score of 4-9

          -  Stable dose prior to screening of 6-mercaptopurine (50-150 mg/day 6-MP) [at least 2
             months], Azathioprine (50-100 mg/day) [at least 2 months], and 5-ASA [at least 2
             weeks]

          -  For females of reproductive potential, agree to avoid pregnancy during the study and
             for 3 months following study completion, have a negative serum pregnancy test (b-HCG)
             at screening and negative urine pregnancy test and use an acceptable method of birth
             control

          -  No history of narcotic and/or alcohol abuse within 2 years of screening and agrees to
             consume < 6 oz. of wine or equivalent per day

          -  No experienced renal or liver disease by history and/or based on laboratory results

          -  Must provide voluntary, written, informed consent prior to screening evaluations and
             be able to follow verbal and written instructions

          -  Must be able to swallow capsules

        Exclusion Criteria:

          -  Primary sclerosing cholangitis

          -  Positive for C. difficile toxin in the stool

          -  Requires hospitalization for treatment of severe ulcerative colitis

          -  History of clinically significant cardiovascular disease (including coronary artery
             disease), clinically significant hepatic, respiratory or renal abnormalities, or
             clinically significant endocrine disorders (not including diabetes)

          -  Clinically significant abnormalities on laboratory results (renal insufficiency, liver
             function abnormalities, abnormal WBC or ANC)

          -  Any clinically significant unstable medical abnormality, chronic disease, or active,
             serious clinical infection or condition, other than ulcerative colitis

          -  Uncontrolled hypertension defined as systolic BP > 160 mmHg and/or diastolic BP > 100
             mmHg on three or more assessment on more than one day(blood pressure must be stable
             for > 3 months prior to screening)

          -  Malignancy within the past 5 years, except for successfully treated basal cell
             carcinoma of the skin

          -  Requiring or receiving anti-TNF-a or other immune modulating drugs (other than 6-MP or
             azathioprine) within 8 weeks prior to screening

          -  Requiring or receiving any of the following within 4 weeks of the screening visit:
             interleukins, steroids (i.e., anabolic steroids, glucocorticoids), narcotics,
             anti-cancer chemotherapeutic agents, metabolic inhibitors or nutraceuticals with
             immune enhancement claims

          -  Requiring oral or intravenous cortisone

          -  Requiring corticosteroid enemas

          -  Acute illness within 10 days prior to Day 1 or taking antibiotics for UC (but not for
             a infectious disease) within 14 days of Day 1

          -  Any clinical condition or receiving therapy that, in the opinion of the Investigator,
             would make the patient unsuitable for study or unable to comply with the dosing
             requirements