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an undetermined dose of GSK1292263

Phase 1

Dyslipidaemias | Small molecule | Cardiovascular |GSK plc|Last Updated: Jul 7, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment76

FDA Designations

No designations recorded

Clinical trial landscape

an undetermined dose of GSK1292263 · 1 trial · 1 indication

Phase 1 1
NCT00783549A Study in Healthy Volunteers of Single Doses of Orally Administered Investigational Product to Investigate Safety, Tolerability, and Pharmacokinecs.Dyslipidaemias
COMPLETED76 Analytics
PHASE1COMPLETED
A Study in Healthy Volunteers of Single Doses of Orally Administered Investigational Product to Investigate Safety, Tolerability, and Pharmacokinecs.
DyslipidaemiasUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability parameters including adverse events, clinical laboratory, electrocardiogram, and vital signs assessments.
Up to 4 days
Pharmacokinetic parameters, maximum observed plasma drug concentration, time to maximum observe.
Up to 4 days

Secondary Endpoints

Pharmacodynamic endpoints
Up to four days.
• Pharmacokinetic parameters following a dose, with and without food, and bioavailability
Up to four days.
Relationships betwen drug exposures and pharmacodynamic parameters, safety, and tolerability, as appropriate.
Up to four days.
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTAL6 active 2 placebo
Cohort 2EXPERIMENTAL9 active 3 placebo
Cohort 3EXPERIMENTALOptional cohort
Cohort 4EXPERIMENTAL12 active
Cohort 5EXPERIMENTAL12 active

Interventions

NameTypeDescription
an undetermined dose of GSK1292263DRUGGSK investigational product or placebo
ascending dose of GSK1292263DRUGAscending dose based on target exposures or placebo
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Male or female between 18 and 55 years of age * A female subject is eligible to participate if she is of non-childbearing potential * Male subjects must agree to use one of the contraception methods listed in the protocol * BMI within the range 20 - 29.9 kg/m2 * Capabl...

Countries:United States
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Frequently asked questions about an undetermined dose of GSK1292263

What is GSK1292263 used for?

GSK1292263 is an investigational small molecule being studied for the treatment of dyslipidaemias, a group of disorders characterized by abnormal levels of lipids in the blood. It is currently in Phase 1 clinical development and has not been approved for any use.

Who is developing GSK1292263?

GSK1292263 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is in Phase 1 clinical development for dyslipidaemias.

What phase is GSK1292263 in?

GSK1292263 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 1 study in healthy volunteers has been completed to assess its safety, tolerability, and pharmacokinetics.

What clinical trials has GSK1292263 been in?

GSK1292263 has been studied in one completed Phase 1 clinical trial, identified as NCT00783549. This trial enrolled 76 participants in the United States and investigated the safety, tolerability, and pharmacokinetics of single oral doses of the drug in healthy volunteers.

Is GSK1292263 being studied in healthy volunteers?

Yes, GSK1292263 has been studied in healthy volunteers. The completed Phase 1 trial NCT00783549 enrolled healthy adult participants aged 18 years and older in the United States. The study was randomized and controlled, and it evaluated the safety, tolerability, and pharmacokinetics of the drug.