A Phase 1, Single-Center, Open-label, Infusion Dose Optimization Study of ABP-700 in Healthy, Adult Subjects

Completed

Conditions: anesthesia
Not applicable

Registration Number: NL-OMON42498

Lead Sponsor: Annovation Biopharma, Inc. (a wholly owned subsidiary of The Medicines Company)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

1. Healthy, adult, men and women, 18-55 years of age, inclusive.

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
<p>Safety will be monitored through AEs, physical examination, safety laboratory<br /><br>tests (serum chemistry, hematology, arterial blood gas, urinalysis, and<br /><br>coagulation), serum methanol concentration (for subjects receiving a total dose<br /><br>of ABP-700 that is above what has already been tested in clinical studies),<br /><br>vital signs (blood pressure [including mean arterial pressure], heart rate, RR,<br /><br>SpO2 and body temperature), ECGs (12-lead continuous Holter, 3-lead telemetry<br /><br>and 12-lead ECGs at screening, check-in, 12 hours post-dose and follow-up),<br /><br>infusion site reaction monitoring, and respiratory function (respiratory<br /><br>pattern and occurrence of apnea).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The PK properties of ABP-700 will be evaluated by assessing the following PK<br /><br>parameters from plasma concentrations from venous and arterial samples: Cmax,<br /><br>AUC0-t, AUC0-inf, tmax, tlast, kel, t1*2, CL, Vz (from venous samples only).<br /><br>The PK of the metabolite (CPM-acid) will also be computed when possible from<br /><br>venous and arterial samples.<br /><br>Dose-proportionality will be evaluated using the power model.<br /><br>The PD profile of ABP-700 and the pre-treatment will be evaluated using the<br /><br>following markers:<br /><br>- MOAA/S scores [ranging from 0 (does not respond to painful trapezius squeeze)<br /><br>to 5 (responds readily to name spoken in normal tone).<br /><br>- BIS scores [ranging from 0 100].<br /><br>- Clinical signs.<br /><br><br /><br>The following ECG parameters will be provided (extracted from 12-lead Holter<br /><br>ECG) for all timepoints: RR, PR, QRS, QT, QTcF, QTcI, Heart Rate, T- and U-<br /><br>wave morphology classifications.</p><br>