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MT400

Phase 1

Undisclosed | Small molecule | Other |GSK plc|Trials Updated: Apr 16, 2015

MT400 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLEDDMC
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

MT400 clinical trials

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 developed by GSK plc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific therapeutic indication for MT400 has not been disclosed, and the compound remains in early clinical development rather than being an approved medicine.

Who makes MT400?

MT400 is made and developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 1 study of MT400 conducted in the United States. The company holds the development program for this investigational small molecule asset.

What phase is MT400 in?

MT400 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. Because only early-stage testing has been conducted, MT400 is investigational and has not been approved by the FDA for any indication.

What clinical trials has MT400 been studied in?

MT400 has been evaluated in one completed Phase 1 trial, NCT00596245. That study was an open-label, placebo-controlled, parallel group trial in healthy volunteers assessing the effects of two single MT400 or naproxen sodium tablets. It enrolled 42 participants in the United States.

What was the design of the MT400 Phase 1 trial?

The MT400 Phase 1 trial, NCT00596245, was an open-label, placebo-controlled, parallel group study in healthy volunteers. It enrolled 42 participants aged 18 years and older of all sexes in the United States. The study compared two single MT400 or naproxen sodium tablets and has been completed.