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Purinethol

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Purinethol · 1 trial · 1 indication

Phase 1 1
NCT00648336Fasting Study of Mercaptopurine 50 mg and Purinethol® Tablets 50 mgHealthy
COMPLETED60 Analytics
PHASE1COMPLETED
Fasting Study of Mercaptopurine 50 mg and Purinethol® Tablets 50 mg
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Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALMercaptopurine 50 mg
2ACTIVE_COMPARATORPurinethol® Tablets 50 mg

Interventions

NameTypeDescription
Mercaptopurine 50 mgDRUG50mg, single dose fasting
Purinethol® Tablets 50 mgDRUG50mg, single dose fasting
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male 3. Volunteers are to be sterile (documentation required) or during the course of the study, from study screen until 3 months after study exit, non-sterile male volunteers must use a spermicide-containing barrier method of contraception to...

Countries:United States
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Frequently asked questions about Purinethol

What is Purinethol used for?

Purinethol is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with one completed trial involving 60 participants. The drug is being developed by Viatris Inc. (VTRS).

Who makes Purinethol?

Purinethol is being developed by Viatris Inc., a company traded on the stock exchange under the ticker VTRS. The drug is currently in Phase 1 clinical development.

What phase is Purinethol in?

Purinethol is in Phase 1 clinical development. It has one completed trial with 60 healthy male participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Purinethol in?

Purinethol has one completed clinical trial, NCT00648336, titled 'Fasting Study of Mercaptopurine 50 mg and Purinethol Tablets 50 mg'. This Phase 1 study enrolled 60 healthy male participants in the United States.

Is Purinethol the same as mercaptopurine?

Purinethol is being studied in a clinical trial that compares it to mercaptopurine 50 mg tablets. The trial NCT00648336 is a fasting study that evaluates both Purinethol and mercaptopurine in healthy volunteers.