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MT400

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLEDDMC
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

MT400 · 1 trial · 1 indication

Phase 1 1
NCT00596245Open-Label, Placebo-Controlled, Parallel Group Study in Healthy Volunteers to Evaluate the Effects of Two Single MT 400 or Naproxen Sodium TabletsHealthy
COMPLETED42 Analytics
PHASE1COMPLETED
Open-Label, Placebo-Controlled, Parallel Group Study in Healthy Volunteers to Evaluate the Effects of Two Single MT 400 or Naproxen Sodium Tablets
HealthyUnlock trial analytics

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 to 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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Frequently asked questions about MT400

What is MT400?

MT400 is an investigational small molecule being developed by GSK plc (GSK). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and its therapeutic area is classified as Other. As of now, MT400 is not approved and remains in clinical trials.

What is MT400 used for?

MT400 is being studied for use in healthy volunteers. The completed Phase 1 trial evaluated the effects of MT400 in healthy individuals. The drug's specific intended indication has not been established, and it remains in early-stage clinical development.

Who makes MT400?

MT400 is developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the safety and effects of MT400 in healthy volunteers.

What phase is MT400 in?

MT400 is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials currently. The drug is investigational and has not been approved for any use.

What clinical trials is MT400 in?

MT400 has one completed clinical trial, identified as NCT00596245. This was an open-label, placebo-controlled, parallel group study in healthy volunteers to evaluate the effects of two single MT400 or naproxen sodium tablets. The trial enrolled 42 participants in the United States.