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6 mercaptopurine

Phase 1

Crohns Disease | Small molecule | Gastrointestinal |Teva Pharmaceutical Industries Limited|Last Updated: Jul 17, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

6 mercaptopurine · 1 trial · 1 indication

Phase 1 1
NCT00774982Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease PatientsCrohns Disease
COMPLETED12 Analytics
PHASE1COMPLETED
Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease Patients
Crohns DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

PK parameters: AUC, Cmax and Tmax
Following single dose of test or reference drug

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
1 6MP Test FormulationEXPERIMENTAL1 x 40 mg Oral Tablet, 6 MP Delayed Release Test Formulation, for targeted ileal delivery
2. 6MP Reference FormulationACTIVE_COMPARATOR2 x 50 mg oral tablet, PURINETHOL

Interventions

NameTypeDescription
Delayed Release 6 mercaptopurineDRUGoral tablet, 1 x 40 mg Delayed Release 6MP tablet, single-dose
6 MercaptopurineDRUGOral Tablet, 2 x 50 mg 6MP Reference, single-dose
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 12 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...

Countries:Israel
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Frequently asked questions about 6 mercaptopurine

What is 6 mercaptopurine used for in Crohn's Disease?

6 mercaptopurine is a small molecule being studied for use in Crohn's Disease, a gastrointestinal condition. It is currently in Phase 1 clinical development as an investigational therapy. The drug has been evaluated in a pilot comparative bioavailability study involving patients with Crohn's Disease.

Who makes 6 mercaptopurine?

6 mercaptopurine is being developed by Teva Pharmaceutical Industries Limited, which is publicly traded under the ticker TEVA. The company is conducting clinical research on this small molecule for the treatment of Crohn's Disease.

What phase is 6 mercaptopurine in?

6 mercaptopurine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, with no active trials currently ongoing for this asset.

What clinical trials is 6 mercaptopurine in?

6 mercaptopurine has one completed clinical trial registered as NCT00774982, titled 'Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease Patients.' This Phase 1 study enrolled 12 participants in Israel and was active-controlled, though not double-blinded.

Is 6 mercaptopurine the same as Purinethol?

6 mercaptopurine is being studied in comparison to Purinethol in a clinical trial. The trial NCT00774982 is a comparative bioavailability study of 6 mercaptopurine in a delayed release formulation versus Purinethol, indicating they are distinct formulations being evaluated for Crohn's Disease.