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ABP-700

Phase 2

Colonoscopy | Small molecule | Other |Novartis AG|Last Updated: Feb 20, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

ABP-700 · 1 trial · 1 indication

Phase 2 1
NCT02800590Study to Investigate the Safety and Efficacy of 3 Dosing Regimens of ABP-700 for Procedural Sedation in Adult Participants Undergoing ColonoscopyColonoscopy
COMPLETED150 Analytics
PHASE2COMPLETED
Study to Investigate the Safety and Efficacy of 3 Dosing Regimens of ABP-700 for Procedural Sedation in Adult Participants Undergoing Colonoscopy
ColonoscopyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose
Treatment period (Day 1)

Secondary Endpoints

Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose with and without Supplemental Bolus ABP-700
Treatment period (Day 1)
Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose with and without Supplemental Bolus ABP-700 that Require or Do Not Require Rescue Sedative Medication
Treatment period (Day 1)
Time to Procedure Start
Treatment period (Day 1)
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABP-700 30 μg/kg/minEXPERIMENTALStarting intravenous (IV) infusion rate of 50 micrograms per kilogram per minute (μg/kg/min) for 5 minutes, followed by 30 μg/kg/min until the procedure is complete. Up to 2 supplemental bolus injections of 50 μg/kg ABP-700 separated by a minimum of 5 minutes may be administered in order to achieve and/or maintain adequate procedure conditions.
ABP-700 40 μg/kg/minEXPERIMENTALStarting IV infusion rate of 70 μg/kg/min for 3 minutes, followed by 40 μg/kg/min until the procedure is complete. Up to 2 supplemental bolus injections of 50 μg/kg ABP-700 separated by a minimum of 5 minutes may be administered in order to achieve and/or maintain adequate procedure conditions.
ABP-700 45 μg/kg/minEXPERIMENTALStarting IV infusion rate of 80 μg/kg/min for 3 minutes, followed by 45 μg/kg/min until the procedure is complete. Up to 2 supplemental bolus injections of 50 μg/kg ABP-700 separated by a minimum of 5 minutes may be administered in order to achieve and/or maintain adequate procedure conditions.

Interventions

NameTypeDescription
ABP-700DRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Participant must be male or female 18 to 75 years of age, inclusive * Participant must give written informed consent before initiation of any study-related procedures * Participant is scheduled to undergo elective colonoscopy * Body Mass Index (BMI) 18.0 to 29.0 kilogram per m...

Countries:Netherlands
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Frequently asked questions about ABP-700

What is ABP-700 used for?

ABP-700 is an investigational small molecule being studied for procedural sedation in adult patients undergoing colonoscopy. It is being developed by Novartis AG (NYSE: NVS). The drug is currently in Phase 2 clinical development and is not approved by the FDA.

Who is developing ABP-700?

ABP-700 is being developed by Novartis AG, a pharmaceutical company traded on the NYSE under the ticker NVS. The drug is an investigational small molecule in Phase 2 clinical development for procedural sedation during colonoscopy procedures.

What phase is ABP-700 in?

ABP-700 is in Phase 2 clinical development. It is an investigational drug being studied for procedural sedation in adult patients undergoing colonoscopy. The drug is not FDA approved and remains under clinical investigation.

What clinical trials is ABP-700 in?

ABP-700 has one completed Phase 2 clinical trial, identified as NCT02800590. This study investigated the safety and efficacy of three dosing regimens of ABP-700 for procedural sedation in adult participants undergoing colonoscopy. The trial enrolled 150 participants and was conducted in the Netherlands.

Is ABP-700 the same as any other drug?

ABP-700 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being developed by Novartis AG for procedural sedation in colonoscopy.