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GSK971086

Phase 1

Healthy Subjects | Small molecule | Endocrine |GSK plc|Last Updated: Mar 19, 2012

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

Clinical trial landscape

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 used for?

GSK971086 is an investigational small molecule being studied in healthy subjects and in the context of androgen deficiency. It is in Phase 1 clinical development for endocrine-related conditions. The drug is not approved and remains under investigation.

Who makes GSK971086?

GSK971086 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety, tolerability, and blood levels of this investigational drug.

What phase is GSK971086 in?

GSK971086 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Its safety and efficacy are still being evaluated in early-stage clinical trials.

What clinical trials is GSK971086 in?

GSK971086 has one completed Phase 1 clinical trial, identified as NCT00540553. This study tested the safety, tolerability, and blood levels of GSK971086 after a single dose and after 7 days of dosing in healthy adult males. The trial enrolled 126 participants in the United States.

Is GSK971086 the same as any other drug?

No alternative names for GSK971086 have been disclosed. The drug is identified solely by its code name GSK971086 in clinical trial registries and by its developer, GSK plc.