A Short Term Pharmacokinetic, Pharmacodynamic and Tolerability Study to Compare AOP200704 vs. Esmolol

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Pharmacokinetics, pharmacodynamics and tolerability of AOP200704 infusion is compared to that of Esmolol by measurement of plasma concentrations of AOP200704, esmolol and their metabolites, by assessing the effect of both drugs on dobutamine-induced tachycardia, and by monitoring vital signs, ECG and adverse events.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AOP Orphan Pharmaceuticals AG
• Treatments: Esmolol

Criteria

Inclusion Criteria:

• Male and female human subjects, age 18-45 years

• Body weight of at least 50 kg, maximum of 90 kg. Body-mass index 18.5 to 30.0 kg/m2

• Caucasians

• Subjects without clinically relevant abnormalities

• Subjects agreeing to not using any prescription and over the counter medications including vitamins and minerals for 7 days prior to study and during the course of the study

• No drug or alcohol abuse

• Non-smokers, ex smokers and mild smokers

Exclusion Criteria:

• Subjects with history or presence of clinically relevant cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological, psychiatric or skin diseases.

• Subjects with bradycardia (heart rate below 50 bpm), tachycardia (heart rate above 100 bpm), hypotension (systolic blood pressure below 100 mmHg, and/or diastolic blood pressure below 70 mm Hg) at screening, clinically relevant or history of clinically relevant arrhythmias

• Subjects with clinically relevant cardiac supraventricular or ventricular arrhythmias.

• Subjects with atrioventricular block of grade II and III, sick sinus syndrome, sinoatrial block or congestive heart failure

• Participation in a clinical drug study or bioequivalence study 60 days prior to present study.

• History of malignancy or other serious diseases.

• Any contraindication to blood sampling.

• History of i.v. drug abuse.

• Subjects with positive HIV tests, HBsAg or Hepatitis C tests or other acute, subacute or chronic infectious disease.