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GSK561679 or

Phase 1

Healthy Subjects | Small molecule | Other |GSK plc|Last Updated: Oct 19, 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

GSK561679 or · 1 trial · 1 indication

Phase 1 1
NCT00539136A Study to Examine the Absorption of GSK561679 in Healthy Male VolunteersHealthy Subjects
COMPLETED12 Analytics
PHASE1COMPLETED
A Study to Examine the Absorption of GSK561679 in Healthy Male Volunteers
Healthy Subjects
NCT0053913612
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Study Endpoints

Primary Endpoints

Pharmacokinetic scope of GSK561679 after application in a solution and in a new tablet formula per treatment phase Complete gastric emptying of radioactive marker after application of GSK561679 Complete tablet breakdown per treatment phase

Secondary Endpoints

AUC(0-24h), AUC(0-t), AUC(0-∞) of GSK561679 after administration of GSK561679 in a solution (fasted) and in a new "optimized" tablet formulation (fasted and fed).
lambda_Z (and t1/2), tlag, Ka, the time to absorb the 25, 50 and 90% of the total absorbed dose
•Other pharmacokinetic parameters of GSK561679 per treatment phase •Safety and tolerability parameters, including adverse events, clinical laboratory,vital signs and 12-lead ECGs measured at each dosing period and throughout the study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeDIAGNOSTIC

Interventions

NameTypeDescription
GSK561679 tablet or solutionDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males aged 18-55 years, inclusive. * Healthy subjects, defined as individuals who are free from clinically significant illness or disease (including peptic ulcer disease and psychiatric illness) as determined by their medical and psychiatric history (including family),...

Countries:United States
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Frequently asked questions about GSK561679 or

What is GSK561679 used for?

GSK561679 is an investigational small molecule being studied for psychiatric conditions, including major depressive disorder, social phobia, and use in healthy subjects. It has been evaluated in clinical trials for these indications, with the most advanced study being a Phase 2 trial in females with major depressive disorder.

What does GSK561679 target?

GSK561679 is a small molecule being developed for psychiatric indications. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for its potential effects on major depressive disorder and social phobia.

Who makes GSK561679?

GSK561679 is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker symbol GSK. GSK is conducting clinical trials to evaluate the drug's safety and efficacy in psychiatric conditions.

What phase is GSK561679 in?

GSK561679 is in Phase 2 clinical development. A Phase 2 trial in females with major depressive disorder has been completed. Earlier Phase 1 studies in healthy subjects and in individuals with social phobia have also been completed.

What clinical trials is GSK561679 in?

GSK561679 has been studied in three completed clinical trials. NCT00733980 is a Phase 2 study in females with major depressive disorder. NCT00555139 is a Phase 1 study in social phobia. NCT00539136 is a Phase 1 study in healthy male volunteers.

Is GSK561679 the same as any other drug?

GSK561679 is the primary name used for this investigational drug in clinical trial registrations. No alternative names have been identified in the available trial information. The drug is being developed by GSK plc under this designation.