This is a phase II, two-part, multiple-dose, dose-finding, single-blind study in adult participants undergoing elective colonoscopy for screening or diagnostic purposes. This study is designed to test various ABP-700 infusion regimens for rational selection of one or more dosage regimen(s) to be used for future clinical development of ABP-700 in procedural sedation.
In Part 1, three ABP-700 two-stage infusion regimens will be evaluated. A sample size of 75 evaluable participants will be randomly assigned to dose regimens in a 1:1:1 ratio. Following the completion of Part 1, a Data Review Committee (DRC) will review the dose-response, efficacy, and safety data and provide recommendations on whether to continue the study to Part 2 and the number of ABP-700 infusion regimens to be included in Part 2. The Sponsor (MDCO) will make the final decision to proceed with Part 2 (whether to conduct Part 2 and number of dose regimens if the study continues to Part 2) based on the recommendation from the DRC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
Martini Hospital
Groningen, Netherlands
University Medical Center Groningen (UMCG)
Groningen, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose
Time frame: Treatment period (Day 1)
Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose with and without Supplemental Bolus ABP-700
Time frame: 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
Time frame: Treatment period (Day 1)
Time to Procedure Start
Time frame: Treatment period (Day 1)
Depth and Duration of Sedation
Time frame: Treatment period (Day 1)
Number of Supplemental ABP-700 Bolus Doses Required
Time frame: Treatment period (Day 1)
Recovery from Sedation and Discharge Conditions as Assessed by the Modified Aldrete Score (APRS)
Time frame: Treatment period (Day 1)
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