A Phase 1, Single-Center, Open-Label, Induction Dose Study of ABP-700 in Healthy, Adult Subjects
Recruiting
- Conditions
- Healthy Volunteers
- Registration Number
- NL-OMON19900
- Lead Sponsor
- The Medicines Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of induction doses of ABP-700. To determine dosing regimens that reliably produce drug induced unconsciousness and the pharmacodynamic conditions necessary for induction of general anesthesia with ABP-700 alone and in combination with fentanyl and midazolam.<br>
- Secondary Outcome Measures
Name Time Method To characterize the pharmacokinetics (PK) of ABP-700 and its primary metabolite (CPM-acid).<br /><br>To assess the pharmacodynamics (PD) of ABP-700.<br /><br>To investigate dose response and PK/PD relationships.<br>