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GI267119

Phase 1

Mental Disorders | Small molecule | Psychiatry |GSK plc|Last Updated: Sep 12, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

GI267119 · 1 trial · 1 indication

Phase 1 1
NCT00410371Study to Compare Two Formulations of Lamotrigine in Healthy SubjectsMental Disorders
COMPLETED96 Analytics
PHASE1COMPLETED
Study to Compare Two Formulations of Lamotrigine in Healthy Subjects
Mental DisordersUnlock trial analytics

Study Endpoints

Primary Endpoints

Lamotrigine AUC(0-inf) and Cmax
Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours

Secondary Endpoints

tmax and t1/2, Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rateTime points
throughout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GI267119EXPERIMENTAL25 mg ODT tablet strength

Interventions

NameTypeDescription
LamotrigineDRUGLamotrigine
GI267119DRUG25 mg ODT
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Eligibility Criteria

Age Range19 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body weight \>50 kg (males) or \>45 kg (females) and BMI within the range 19 to 30 kg/m2 inclusive. Exclusion Criteria: * Female subjects of childbearing potential will not be eligible to participate if they are unwilling or unable to use an appropriate method of contracepti...

Countries:United States
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Competitive Landscape -Mental Health Disorders 10 trials (matched to "Mental Disorders")

No competing companies are currently tracked in active development for Mental Health Disorders.
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Frequently asked questions about GI267119

What is GI267119 used for?

GI267119 is an investigational small molecule being developed for mental disorders. It is in Phase 1 clinical development, meaning it is still being studied in early-stage trials and has not been approved for any use. The drug is being evaluated for its safety and tolerability in healthy volunteers.

Who makes GI267119?

GI267119 is being developed by GSK plc, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol GSK. The company is conducting clinical research on this investigational small molecule for the treatment of mental disorders.

What phase is GI267119 in?

GI267119 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing early-stage clinical trials to assess its safety and tolerability in humans.

What clinical trials is GI267119 in?

GI267119 has been studied in one completed Phase 1 clinical trial, identified as NCT00410371. This trial, titled 'Study to Compare Two Formulations of Lamotrigine in Healthy Subjects,' enrolled 96 participants in the United States and was a randomized, uncontrolled study in healthy volunteers aged 19 years and older.

Is GI267119 the same as lamotrigine?

GI267119 is an investigational drug being studied in a clinical trial that compares two formulations of lamotrigine, a medication used for mental disorders. The trial is designed to evaluate the pharmacokinetics of these formulations, and GI267119 is the investigational product being tested in this context.