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RSG

Phase 1

Alzheimer's Disease | Small molecule | Neurology |GSK plc|Last Updated: Aug 7, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

RSG · 1 trial · 1 indication

Phase 1 1
NCT00468897A Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites.Alzheimer's Disease
COMPLETED50 Analytics
PHASE1COMPLETED
A Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites.
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

PK samples
at Pre-dose,0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32

Secondary Endpoints

Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements.
Up to 32
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Arm ABEXPERIMENTALA will be a single tablet RSG XR 8 milligram (mg) manufactured in Harlow administered in the fasted state and B will be a single tablet RSG XR 8 mg manufactured in Crawley administered in the fasted state. In Arm AB subject will receive A regimen in Period 1 and B regimen in Period 2.There will be wash-out period of 5 days between doses.
Treatment Arm BAEXPERIMENTALA will be a single tablet RSG XR 8 mg manufactured in Harlow administered in the fasted state and B will be a single tablet RSG XR 8 mg manufactured in Crawley administered in the fasted state. In Arm BA subject will receive B regimen in Period 1 and A regimen in Period 2. There will be wash-out period of 5 days between doses.

Interventions

NameTypeDescription
RSG XRDRUGRSG XR tablets 8 mg enteric-coated tablet formulation consisting of 3mg fast release plus 5mg slow release. Subject will receive one 8mg of RSG XR on each dosing day. The subject will receive a single oral dose of regiment A or B with 240 milliliter (mL) of water.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female aged 18-55 years. * BMI between 19 - 30 kg/m2 Exclusion criteria: * Liver function tests above the upper limit * Excessive alcohol consumption history * History of Cigarette smoking * Positive HIV, Hep B or C test * Positive pregnancy test * History of...

Countries:Germany
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Frequently asked questions about RSG

What is RSG used for in Alzheimer's Disease?

RSG is a small molecule being investigated for the treatment of Alzheimer's Disease. It is currently in Phase 1 clinical development. The drug is being studied for its potential effects on the condition, though it remains investigational and has not been approved for any use.

Who makes RSG?

RSG is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical research on this small molecule for Alzheimer's Disease.

What phase is RSG in?

RSG is in Phase 1 clinical development. It is an investigational drug being studied for Alzheimer's Disease. The drug has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and potential efficacy.

What clinical trials is RSG in?

RSG has one completed clinical trial registered under the identifier NCT00468897. This Phase 1 study was conducted in Germany and enrolled 50 participants. The trial was a controlled, randomized study that included healthy volunteers, with a minimum age of 18 years.

Is RSG the same as rosiglitazone?

RSG is a designation for the drug rosiglitazone, which is also known by the code name BRL-049653. The clinical trial for RSG specifically studied rosiglitazone XR (extended release) at an 8 mg dose, manufactured at two different sites.