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GSK586529

Phase 1

Depressive Disorder and Anxiety Disorders | Small molecule | Psychiatry |GSK plc|Trials Updated: Aug 22, 2017

GSK586529 target and mechanism

ModalitySmall molecule

Also known as GSK586529 capsules

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

GSK586529 clinical trials

GSK586529 · 1 trial · 1 indication

Phase 1 1
NCT00703547A First Time in Human Study of GSK586529 in Healthy VolunteersDepressive Disorder and Anxiety Disorders
COMPLETED21 Analytics
PHASE1COMPLETED
A First Time in Human Study of GSK586529 in Healthy Volunteers
Depressive Disorder and Anxiety DisordersUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics
Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

Secondary Endpoints

Blood levels of GSK586529 to determine pharmacokinetic parameters
Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
Urinary recovery of GSK586529
Pre-dose, 0-6, 6-12, 12-24, 24-48, 48-72 and 72-96 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
ModelCROSSOVER
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Subjects receiving treatment in cohort 1EXPERIMENTALSubjects will receive one of the following sequences; ABDF,BADF, BDAF or BDFA (A=Placebo, B= GSK586529 dose 1 (3 milligrams), D = GSK586529 dose 3, F = GSK586529 dose 5).
Subjects receiving treatment in cohort 2EXPERIMENTALSubjects will receive one of the following sequences; ACEG,CAEG, CEAG or CEGA (A = Placebo, C= GSK586529 dose 2, E = GSK586529 dose 4, G = GSK586529 dose 6)

Interventions

NameTypeDescription
GSK586529 capsulesDRUGGSK586529 will be provided as white gelatin capsule with a dose of 3 milligrams.
GSK586529 tabletsDRUGGSK586529 will be provided as a yellow film-coated tablets for oral administration at three different strengths 10 milligrams, 60 milligrams and 120 milligrams.
PlaceboDRUGPlacebo tablets and capsules will be provided to subjects.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males aged 18-45 years, inclusive. * Healthy subjects, defined as individuals who are free from clinically significant illness or disease as determined by their (and familial) medical and psychiatric history, physical examination, laboratory studies, and other tests. *...

Countries:United Kingdom
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Frequently asked questions about GSK586529

What is GSK586529?

GSK586529 is an investigational small molecule developed by GSK plc for depressive disorder and anxiety disorders. It has been studied in a first-time-in-human Phase 1 trial in healthy volunteers. It is not an approved medicine and remains in clinical development.

What is GSK586529 used for?

GSK586529 is being developed for depressive disorder and anxiety disorders. The only reported clinical study enrolled healthy volunteers rather than patients, so the compound has not yet been evaluated for treatment effect in people with these conditions.

Who makes GSK586529?

GSK586529 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the first-time-in-human study of the compound, which was conducted in the United Kingdom.

What phase is GSK586529 in?

GSK586529 is in Phase 1 development. One Phase 1 first-time-in-human study has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any indication.

What clinical trials has GSK586529 been studied in?

GSK586529 has been studied in one completed Phase 1 trial, NCT00703547, titled A First Time in Human Study of GSK586529 in Healthy Volunteers. It enrolled 21 male healthy volunteers aged 18 years and older in the United Kingdom and used a controlled, randomized design.

Is GSK586529 the same as GSK586529 capsules?

Yes. GSK586529 capsules is another name used for GSK586529, the investigational small molecule from GSK plc. Both names refer to the same compound studied in the Phase 1 trial NCT00703547 for depressive disorder and anxiety disorders.