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GSK971086

Phase 1

Androgen Deficiency | Small molecule | Endocrine |GSK plc|Trials Updated: Mar 19, 2012

GSK971086 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment126

FDA Designations

No designations recorded

GSK971086 clinical trials

GSK971086 · 1 trial · 2 indications

Phase 1 1
NCT00540553Study to Test Safety, Tolerability and Blood Levels of GSK971086 After 1 Dose & 7 Days of Dosing in Healthy Adult MalesHealthy Subjects
COMPLETED126 Analytics
PHASE1COMPLETED
Study to Test Safety, Tolerability and Blood Levels of GSK971086 After 1 Dose & 7 Days of Dosing in Healthy Adult Males
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events:
all visits
hematology, clinical chemistry, urinalysis:
Part A Days -2,2,3,14,28 & Part B Days -2,2,5,8,14,21,35
vital signs & 12-lead ECGs:
Part A Days -2-3,7,28 & Part B Days -2-9,14,35

Secondary Endpoints

GSK 971086 Plasma blood level:
art A Days 1,2,3,7,14,21,28 & Part B Days 1-9,14,21,28,35
PBone & muscle biomarkers:
Part A Days 1,2,7,14,21,28 & Part B Days 1,3,8,14,21,28,35
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
placeboDRUG -
GSK971086DRUG -
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Eligibility Criteria

Age Range18 Years to 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males between 18 and 50 years of age (inclusive), at the time of signing the informed consent form. * Healthy, as determined by the Investigator, based on medical evaluations performed during the Screening Period including medical history, physical examination, clinical labora...

Countries:United States
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Frequently asked questions about GSK971086

What is GSK971086?

GSK971086 is an investigational small molecule developed by GSK plc for androgen deficiency. It is a Phase 1 clinical candidate in the endocrine therapeutic area. It has been studied in healthy adult male volunteers to assess safety, tolerability, and blood levels after single and repeat dosing.

What is GSK971086 used for?

GSK971086 is being developed for androgen deficiency, a condition characterized by low levels of male sex hormones. The clinical program has studied it in healthy adult males and in the context of androgen deficiency. It remains investigational and is not an approved treatment.

Who makes GSK971086?

GSK971086 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 1 clinical study of the compound in the United States. GSK plc is the sole developer named for this asset.

What phase is GSK971086 in?

GSK971086 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is GSK971086 in?

GSK971086 has been evaluated in one completed Phase 1 trial, NCT00540553, titled a study to test safety, tolerability, and blood levels after one dose and seven days of dosing in healthy adult males. The trial enrolled 126 participants in the United States and was randomized and double blind.

What does GSK971086 target?

GSK971086 is a small molecule being developed for androgen deficiency. It was studied in a Phase 1 trial measuring safety, tolerability, and blood levels after single and repeat dosing in healthy adult males. No molecular target is specified for this compound.