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Safety and Pharmacokinetics Study of HE3286 in Patients With Active, Mild-to-Moderate Ulcerative Colitis
This study is currently recruiting participants.
Verified by Hollis-Eden Pharmaceuticals, December 2008
First Received: February 25, 2008   Last Updated: December 9, 2008   History of Changes
Sponsored by: Hollis-Eden Pharmaceuticals
Information provided by: Hollis-Eden Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00628433
  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 I
Phase II

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Ulcerative Colitis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
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

Further study details as provided by Hollis-Eden Pharmaceuticals:

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 ]

Estimated Enrollment: 36
Study Start Date: February 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator
Placebo
Drug: Placebo
Placebo
2: Experimental
HE3286 5 mg daily
Drug: HE3286
daily for 28 days
3: Experimental
HE3286 10 mg daily
Drug: HE3286
daily for 28 days
4: Experimental
HE3286 20 mg daily
Drug: HE3286
daily for 28 days
5: Experimental
HE3286 4 mg daily
Drug: HE3286
daily for 28 days

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

Contacts
Contact: Hollis-Eden Pharmaceuticals Clinical Trials 858-320-2591 clinicaltrials@holliseden.com

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

No publications provided

Responsible Party: Hollis-Eden Pharmaceuticals ( Nanette Onizuka-Handa, Sr. Vice President, Regulatory Affairs and Quality )
Study ID Numbers: HE3286-0301
Study First Received: February 25, 2008
Last Updated: December 9, 2008
ClinicalTrials.gov Identifier: NCT00628433     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Hollis-Eden Pharmaceuticals:
phase I/II
ulcerative colitis
safety
tolerance
pharmacokinetics

Study placed in the following topic categories:
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

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

ClinicalTrials.gov processed this record on May 07, 2009