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RSG

Phase 1

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

RSG target and mechanism

ModalitySmall molecule

Also known as RSG XR

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

RSG clinical trials

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?

RSG is an investigational small molecule developed by GSK plc for Alzheimer's Disease. It is also known as RSG XR. The program is in Phase 1 clinical development, and the one recorded trial has been completed. RSG has not been approved for any use based on the available development information.

What is RSG used for in Alzheimer's Disease?

RSG is being studied for Alzheimer's Disease, a neurology indication. Development is at Phase 1, the earliest stage of clinical testing, so RSG is investigational and is not an approved treatment for Alzheimer's Disease or any other condition.

Who makes RSG?

RSG is developed by GSK plc, which trades under the ticker GSK. The company is the sponsor behind the RSG XR program in Alzheimer's Disease, which has reached Phase 1 testing.

What phase is RSG in?

RSG is in Phase 1 clinical development. One trial has been completed and no trials are currently active. Because it remains in early-stage testing, RSG is investigational and has not been approved by the FDA or any other regulator for Alzheimer's Disease.

What clinical trials is RSG in?

RSG has been evaluated in one completed Phase 1 trial, NCT00468897, titled a study to demonstrate the bioequivalence of Rosiglitazone XR (BRL-049653) 8 mgs XR manufactured at two different sites. That trial enrolled 50 participants in Germany, was randomized and controlled, and included healthy volunteers.

Is RSG the same as RSG XR?

Yes, RSG XR is an alternative name for RSG, the GSK plc small molecule being studied in Alzheimer's Disease. The completed Phase 1 trial NCT00468897 refers to the drug as Rosiglitazone XR, or BRL-049653, which is the same asset.