Clinical trial NCT00628433: Safety and Pharmacokinetics Study of HE3286 in Patients With Active, Mild-to-Moderate Ulcerative Colitis
Official title: A Phase I/II, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Activity of HE3286 When Administered Orally to Patients With Active, Mild-to-Moderate Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ulcerative Colitis
Keywords: phase I/II
ulcerative colitis
safety
tolerance
pharmacokinetics
Lead sponsor: Harbor Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-03-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot, exploratory study is to evaluate the safety, tolerance, pharmacokinetics and potential activity of an investigational agent, HE3286, when administered orally, daily for 28 days to patients with mild-to-moderate ulcerative colitis.

Detailed description: HE3286 has a potentially new mechanism of action that may improve the current therapeutic options available to patients with ulcerative colitis. In preclinical experiments, HE3286 has shown activity in animal models of ulcerative colitis. Additionally, HE3286 has shown to have anti-inflammatory activity associated with corticosteroids but without the side effects associated with corticosteroid use, such as immune suppression and bone loss.

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

Primary outcomes:
measure: safety and pharmacokinetics
timeFrame: duration of the study
Secondary outcomes:
measure: assess activity on the signs and symptoms of active mild-to-moderate ulcerative colitis
timeFrame: duration of the study
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Fresno
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Winter Park
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Louisville
country: United States
state: Kentucky
city: El Paso
country: United States
state: Texas
Study officials:
affiliation: Harbor Therapeutics
name: Dwight R Stickney, MD
role: PRINCIPAL_INVESTIGATOR
References: