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

NCT00628433 | Completed Phase 1

• 1 other identifier: HE3286-0301
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 10

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.

Conditions

Ulcerative Colitis

Keywords

phase I/II; ulcerative colitis; safety; tolerance; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• safety and pharmacokinetics

  duration of the study

Secondary Outcomes (1)

• assess activity on the signs and symptoms of active mild-to-moderate ulcerative colitis

  duration of the study

Study Arms (5)

1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

2

EXPERIMENTAL

HE3286 5 mg daily

Drug: HE3286

3

EXPERIMENTAL

HE3286 10 mg daily

Drug: HE3286

4

EXPERIMENTAL

HE3286 20 mg daily

Drug: HE3286

5

EXPERIMENTAL

HE3286 4 mg daily

Drug: HE3286

Interventions

Placebo DRUG

Placebo

1

HE3286 DRUG

daily for 28 days

Also known as: Triolex

2; 3; 4; 5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harbor Therapeutics: lead

Study Sites (10)

Unknown Facility

Tucson, Arizona, 85712, United States

Location

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Fresno, California, 93726, United States

Location

Unknown Facility

La Jolla, California, 92037, United States

Location

Unknown Facility

Denver, Colorado, 80205, United States

Location

Unknown Facility

Denver, Colorado, 80215, United States

Location

Unknown Facility

Winter Park, Florida, 32789, United States

Location

Unknown Facility

Atlanta, Georgia, 30342, United States

Location

Unknown Facility

Louisville, Kentucky, 40536, United States

Location

Unknown Facility

El Paso, Texas, 79905, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

17-ethynyl-5-androstene-3, 7, 17-triol

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Dwight R Stickney, MD

  Harbor Therapeutics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 25, 2008
• First Posted: March 5, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 14, 2011

Record last verified: 2011-06

Locations

US (10)