Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease Patients

NCT00774982 | Completed Phase 1

• 1 other identifier: C1/13/6MP-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the pharmacokinetic parameters (Cmax, Tmax and AUC) of the new delayed release, lowered dose, 40 mg 6MP test formulation as compared to standard 6MP (100 mg Purinethol) in 12 patients with Crohn's Disease. The study is being undertaken to prove that the new test formulation is indeed delayed-release and targeted to the ileum, and that the levels of 6MP in the blood following local absorption are lower than that seen following standard Purinethol dosing. This should result in lower, safer mercaptopurine dosing, allowing for uninterrupted treatment with fewer side effects.

Conditions

Crohns Disease

Keywords

Crohns Disease; Pharmacokinetics; Local Targeted Delivery to the Ileum; Delayed Release; Immunology Measurements; Pharmacokinetics in Crohns Disease Patients

Outcome Measures

Primary Outcomes (1)

• PK parameters: AUC, Cmax and Tmax

  Following single dose of test or reference drug

Secondary Outcomes (1)

• FACS analysis of peripheral blood lymphocytes following single dose of test vs. reference formulation

  Comparison of values from blood collected at 0, 12 and 24 hours post-dose

Study Arms (2)

1 6MP Test Formulation

EXPERIMENTAL

1 x 40 mg Oral Tablet, 6 MP Delayed Release Test Formulation, for targeted ileal delivery

Drug: Delayed Release 6 mercaptopurine

2. 6MP Reference Formulation

ACTIVE COMPARATOR

2 x 50 mg oral tablet, PURINETHOL

Drug: 6 Mercaptopurine

Interventions

Delayed Release 6 mercaptopurine DRUG

oral tablet, 1 x 40 mg Delayed Release 6MP tablet, single-dose

Also known as: Administration 1 (A): 1 x 40 mg Delayed Release 6MP TEST

1 6MP Test Formulation

6 Mercaptopurine DRUG

Oral Tablet, 2 x 50 mg 6MP Reference, single-dose

Also known as: Administration 2 (B): 2 x 50 mg Purinethol REFERENCE

2. 6MP Reference Formulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• male and non-pregnant females, aged 18-50 years, with Crohns Disease (CDAI up to 200), non-smoking.
• Crohns Disease diagnosis via colonoscopy with biopsy within the past 12 years No CD medications allowed during study other than 5-ASA and symptomatic relief (anti-diarrheals) Screening lab tests: HGB\>= 8.5 g/dl, platelets \>= 100,000/mm3, WBC: 3500-12000/mm3, serum albumin above 2.5 g/dl, amylase, lipase and total bilirubin within normal limits; ALT, AST, alkaline phosphatase up to 1.5 x normal limits

You may not qualify if:

• No more than 2 bowel movements/24 hour period in week prior to screening No patients on methotrexate, cyclosporine, or other anti-TNF alpha, or anti-neoplastics within 3 months of study start NO fistulizing CD or isolated small bowle CD No symptomatic stenosis or ileal strictures,or x-ray evidnece of fibrosed bowel

Sponsors & Collaborators

• Teva GTC: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Mercaptopurine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yaron Ilan, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: December 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 17, 2009

Record last verified: 2009-07

Locations

IL (1)