Safety and Pharmacokinetics Study of HE3286 in Patients With Active, Mild-to-Moderate Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by:
Harbor Therapeutics
ClinicalTrials.gov Identifier:
NCT00628433
First received: February 25, 2008
Last updated: June 11, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Drug: Placebo
Drug: HE3286
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Harbor Therapeutics:

Primary Outcome Measures:
  • safety and pharmacokinetics [ Time Frame: duration of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • assess activity on the signs and symptoms of active mild-to-moderate ulcerative colitis [ Time Frame: duration of the study ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: February 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: Placebo
Placebo
Experimental: 2
HE3286 5 mg daily
Drug: HE3286
daily for 28 days
Other Name: Triolex
Experimental: 3
HE3286 10 mg daily
Drug: HE3286
daily for 28 days
Other Name: Triolex
Experimental: 4
HE3286 20 mg daily
Drug: HE3286
daily for 28 days
Other Name: Triolex
Experimental: 5
HE3286 4 mg daily
Drug: HE3286
daily for 28 days
Other Name: Triolex

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628433

Locations
United States, Arizona
Tucson, Arizona, United States, 85712
United States, California
Anaheim, California, United States, 92801
Fresno, California, United States, 93726
La Jolla, California, United States, 92037
United States, Colorado
Denver, Colorado, United States, 80205
Denver, Colorado, United States, 80215
United States, Florida
Winter Park, Florida, United States, 32789
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Kentucky
Louisville, Kentucky, United States, 40536
United States, Texas
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Harbor Therapeutics
Investigators
Principal Investigator: Dwight R Stickney, MD Harbor Therapeutics
  More Information

No publications provided

Responsible Party: Nanette Onizuka-Handa, Sr. Vice President, Regulatory Affairs and Quality, Hollis-Eden Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00628433     History of Changes
Other Study ID Numbers: HE3286-0301
Study First Received: February 25, 2008
Last Updated: June 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Harbor Therapeutics:
phase I/II
ulcerative colitis
safety
tolerance
pharmacokinetics

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014