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MT400

Phase 1

Healthy | Small molecule | Other |GSK plc|Last Updated: Apr 16, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00596245Open-Label, Placebo-Controlled, Parallel Group Study in Healthy Volunteers to Evaluate the Effects of Two Single MT 400 or Naproxen Sodium TabletsPHASE1 COMPLETED 42 — — Oct 1, 2007Dec 1, 2007Apr 16, 20151 United States
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Study Endpoints
Primary Endpoints
The primary objective is to assess the impact on production of chromosomal aberration after dosage of MT 400 or naproxen sodium versus placebo. Comparison of post-dose chromosomal aberration rates will also be made to baseline rates within each arm.
7 days
Secondary Endpoints
Potential subjects will be assessed for exposure to ionizing radiation or working with cytotoxic chemicals.
7 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALMT 400, naproxen sodium 550mg
Interventions
NameTypeDescription
MT400DRUGMT 400, naproxen sodium 550mg
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Eligibility Criteria
Age Range18 Years — 35 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male or female subjects who are 18-35 years of age at the screening visit 2. Female subjects are eligible for participation in the study if they are of: 1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, 2. Childbearing potential,...

Countries:United States
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