The target population is patients that are scheduled to undergo a colonoscopy for screening or diagnostic purposes.
Conditions
Interventions
ABP-700 (cyclopropyl-MOC-metomidate, CPMM), is an intravenous (IV) anesthetic being developed for sedation, monitored anesthesia care (MAC) and/or general anesthesia in patients undergoing therapeutic
g/kg are allowed at the discretion of the anesthesia provider to maintain conditions acceptable for procedure completion. These bolus doses can occur no more frequently than every 5 minutes with no mo
Sponsors
The Medicines Company
8 Sylvan Way
Parsippany, NJ 07054
United States of America
Eligibility
Inclusion criteria
Inclusion criteria: Patients may be included in the study if they meet all of the following criteria: 1. Patient must be male or female 18 - 65 years of age, inclusive. 2. Patient must give written informed consent before initiation of any study-related procedures 3. Patient is scheduled to undergo elective colonoscopy 4. BMI 18.0 – 29.0 kg/m2 5. ASA class I – II 6. Modified Mallampati score I – II 7. If female and of child-bearing potential, patient has negative pregnancy test during screening and is not breast-feeding 8. If patient is a sexually active male or a sexually active female of child-bearing potential, patient agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits.
Exclusion criteria
Exclusion criteria: 1. Any ASA physical status III or worse, or history of one or more of the following: - History or presence of significant cardiovascular disease, or cardiovascular disease risk factors, hyperlipidemia, coronary artery disease, or any known genetic pre disposition to cardiac arrhythmia (including long QT syndrome, > 450 msec) - History of any neurological or seizure disorder or psychiatric disease - History or presence of significant pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic or dermatologic disease - History of any illness that, in the opinion of the PI, might confound the results of the study or pose an additional risk to the patient by their participation in the study 2. History of any recent illness (e.g., upper respiratory infection) that does not satisfy ASA III or greater requirements but in the opinion of the PI, may pose an additional risk to the patient by their participation in the study. 3. Patients with a history of essential hypertension well controlled on medication will be accepted. Subjects should have been diagnosed with hypertension for at least 6 months and should have been on stable therapy for at least 4 weeks prior to the study. 4. Surgery within the past 90 days prior to dosing judged by the PI to be clinically relevant. 5. History of febrile illness within 5 days prior to dosing. 6. Patients in whom airway management is judged to be potentially difficult; thyromental distance ≤4 cm or Mallampati scores of 3 or 4 or per the discretion of the anesthesiologist based on history. 7. History or presence of alcoholism, drug abuse or illicit drug use within the past 2 years. 8. Hypersensitivity or idiosyncratic reaction to components of ABP-700 (sulfobutylether-beta-cyclodextrin, citrate buffer, sodium hydroxide), remifentanil or midazolam. 9. Patient is the Investigator or his/her deputy, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study. 10. Participation in another interventional clinical trial within 90 days prior to dosing. The 90-day window will be derived from the date of the last study procedure (such as last blood collection or dosing) in the previous study to Day 1 of the current study. 11. Patients who, for any reason, are deemed by the Investigator to be inappropriate for this study, including patients who are unable to communicate or to cooperate with the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to test if ABP-700 infusion regimens that produce a range of sedation effects enable successful completion of a colonoscopy in adult patients. Success of the procedure is defined as, procedure completion without the use of alternative rescue sedative medication, or major respiratory impairment as assessed by oxygen saturation off less than 90% or the need for assisted positive pressure ventilation (manual or mechanical). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives of this study are to quantify the pharmacodynamic effect of ABP-700 including time to procedure start, sedation depth, patient recovery and readiness for discharge; and to quantify the cardio-respiratory effects of sedation doses of ABP-700. Further exploratory objectives include: - To determine endoscopist and anesthesiologist satisfaction with the procedure - To determine patient satisfaction with the procedure - To determine patient procedural recall. - To evaluate cognition and memory function of the patient. | — |
Contacts
Public ContactMarieke Geel
Petrus Campersingel 123
Outcome results
None listed