anesthesia Not applicable
Conditions
Sponsors
The Medicines Company
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy, adult, men and women, 18-55 years of age, inclusive, at screening. 2. Continuous non-smoker who has not used nicotine-containing products for at least 6 months prior to the first dose. 3. Body Mass Index (BMI) >= 17.5 and
Exclusion criteria
Exclusion criteria: 1. 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). 2. History or presence of significant pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological (inclusive of any seizure disorder), or psychiatric disease. 3. 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 subject by their participation in 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. History or presence of alcoholism, drug abuse or illicit drug use within the past 2 years. 7. History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men [1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor] within 6 months of screening. 8. Hypersensitivity or idiosyncratic reaction to components of ABP-700 (meglumine and/or sulfobutylether-beta-cyclodextrin), fentanyl, midazolam, egg, egg products, soybeans, soy, or to compounds related to the study medications. 9. History or presence of adrenal insufficiency as defined by serum cortisol level <6 µg/dL at screening. 10. Women who are pregnant or lactating. 11. Positive results for the urine drug screen and alcohol breath test at screening or check-in (Day -1). 12. Positive urine cotinine at screening. 13. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV). 14. Single 12-lead ECG demonstrating QTcF interval >450 msec at screening. 15. Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning approximately 14 days prior to dosing and throughout the study, with the exception of oral contraceptives. Ibuprofen (1.2 g per 24 hour period) may be permitted during the study at the PI*s discretion. 16. Use of any drugs known to be hormonal replacement therapy, inducers of cytochrome P450 (CYP) enzymes, including St. John*s Wort, within 28 days prior to the first dose of study medication. Appropriate sources will be consulted by the PI to confirm lack of PK/PD interaction with study medication(s). 17. Have a diet incompatible with the clinic diet, in the opinion of the PI, within the 28 days prior to the first dose of study medication(s), and throughout the study. 18. Blood donation or significant blood loss within 90 days prior to dosing. 19. Plasma donation within 7 days prior to dosing. 20. Participation in another 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. 21. Subjects who previously received ABP-700.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| PK and PD | — |
Countries
Netherlands
Outcome results
None listed