Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis

NCT01020708 | Completed Phase 1 DMC

• 1 other identifier: ALTH12-003
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase I study will be a closely monitored trial of a small number of subjects to establish, preliminarily, the tolerability and safety of two ALTH12 enema formulations: ALTH12-1:4 and ALTH12-2:4. The study will be conducted in two parts. The first part will be the assessment of the safety and tolerability of a single dose of ALTH12-1:4 or the comparator, mesalamine (4.0g 5-ASA) followed by an assessment of repeated administrations of study drug (ALTH12-1:4 or comparator) for 6 weeks. The second part will be the same assessment for ALTH12-2:4. Three subjects will be enrolled in each cohort: 2 to receive ALTH12 enema therapy and 1 subject to receive comparator enema therapy. A total of up to 9 patients will be enrolled in this study, allowing for up to 3 replacement or additional patients.

Conditions

Ulcerative Colitis

Keywords

colitis; inflammatory bowel disease; ulcerative colitis; rectal administration; enema; mesalamine

Outcome Measures

Primary Outcomes (1)

• To determine the safety and tolerability of ALTH12 when given by intrarectal administration over 6 weeks to subjects with ulcerative colitis (UC) involving the left side of the colon

  6 weeks treatment

Study Arms (3)

Comparator

ACTIVE COMPARATOR

Mesalamine enema

Drug: mesalamine

ALTH12-1:4

EXPERIMENTAL

ALTH12-1:4 experimental treatment dose

Drug: ALTH12-1:4

ALTH12-2:4

EXPERIMENTAL

ALTH12-2:4 experimental treatment dose

Drug: ALTH12-2:4

Interventions

mesalamine DRUG

4.0g mesalamine rectal suspension, rectally administered enema, 60ml volume, 4.0g mesalamine, once daily

Also known as: Rowasa, 5-ASA, 5-aminosalicylic acid

Comparator

ALTH12-1:4 DRUG

ALTH12-1:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 1.0g N-acetylcysteine

Also known as: mesalamine, 5-ASA, N-acetylcysteine, NAC, enema

ALTH12-1:4

ALTH12-2:4 DRUG

ALTH12-2:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 2.0g N-acetylcysteine

Also known as: mesalamine, 5-ASA, N-acetylcysteine, NAC

ALTH12-2:4

Eligibility Criteria

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

You may qualify if:

• Male and female subjects are eligible if they are ≥ 18 years of age and ≤ 64 years
• They have a documented history of idiopathic ulcerative colitis based on endoscopic and/or histologic findings involving the left side of the colon, with mild active disease or disease in remission.
• Eligible subjects will have a documented history of ulcerative colitis, and a modified UCDAI with a sigmoidoscopy score of 1 point or less and Physician's rating of disease score of 1 point or less (mild or remission).
• Laboratory data:
• White blood cell count between 4,500 and 10,000 cells/mL
• Platelet count: 150,000-450,000 cells/mL
• Hemoglobin \> 10.0 g/dL
• Total bilirubin \< 1.5 mg/dL
• Aspartate aminotransferase \< 100 u/dL
• Alanine aminotransferase \< 100 u/dL
• Alkaline phosphatase \< 250 u/dL
• Blood urine nitrogen \< 40 mg/dL
• Creatinine \< 1.5 mg/dL
• Amylase \< 150 U/L
• Satisfied one of the following:

You may not qualify if:

• Subjects will be excluded if:
• They have documented history of proctitis or active proctitis confined to 15cm or less from the anal verge.
• They demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.
• They receive a Physician's rating of disease severity as part of the modified UCDAI of 2 or greater (moderate or severe disease) or an endoscopy score of 2 or greater.
• They have shown evidence of high grade dysplasia on endoscopic examinations.
• Their stool contains enteric pathogens or Clostridium difficile toxins.
• They have a history of recurrent Clostridium difficile infection.
• They have prior history of biologic therapy.
• They have received systemic steroids or immunosuppressants within the previous 4 weeks.
• Treatment in the last 2 weeks that included antibiotic, antifungal, antiparasitic medications, or rectally administered steroids (e.g. Cortenema®) and/or 5-ASA enema (e.g. Rowasa®).
• They have a history of cancer (defined as malignancy within 5 years except for squamous cell or basal cell cancers of the skin), asthma, or bronchospasm.
• Positive pregnancy test or lactating subjects.
• There is evidence of chemical abuse.
• They have a known allergy to N-acetylcysteine or Mesalamine.
• They have a history of failure to retain enemas.

Sponsors & Collaborators

• Altheus Therapeutics, Inc.: lead

Study Sites (1)

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Colitis; Inflammatory Bowel Diseases

Interventions

Mesalamine; Acetylcysteine; Enema

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Drug Therapy; Therapeutics

Study Officials

• Philip B Miner, M.D.

  Oklahoma Foundation for Digestive Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: November 24, 2009
• Study Start: November 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 29, 2011

Record last verified: 2011-03

Locations

US (1)