A Pharmacokinetic, Pharmacodynamic, Safety Study With AOP LDLA202, ONO LDL50 and Esmolol in Healthy Volunteers

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The study consists of a Pilot Phase (to assess safety and the local tolerability of highest AOP LDLA202 dose versus placebo) and a Main Treatment Phase (to compare PK, PD and safety and tolerability of AOP LDLA202, ONO LDL50 and esmolol bolus administrations by measurement of blood concentrations of landiolol, esmolol and their metabolites, and by monitoring ECG, blood pressure and adverse events).

• Phase: Phase 1
• 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, Caucasians

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

• Subjects without clinically relevant abnormalities as determined by baseline medical history, physical examination, blood pressure, heart rate and ear temperature at screening.

• Subjects without clinically relevant abnormalities as determined by blood count, coagulation tests, biochemistry, infectious disease screening, urinalysis, ECG, and 2D Echo at screening.

• Subject is willing and able to undergo procedures required by this protocol and gave written informed consent.

• Agreeing to not using any prescription and over the counter medications

• No history or presence of alcoholism or drug abuse

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, 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.

• Known history of hypersensitivity to any IMP.

• Refusal to abstain from smoking or consumption of tobacco products 48 hours before drug administration and during the study period.

• Refusal to abstain from alcohol, caffeine, or other xanthines, or grapefruit containing food or drinks for 72 hours before drug administration and during the study period.

• Refusal to abstain from strenuous activities for 7 days before screening and end-of-study examinations, before and during each study period.

• Subjects with anomalies of the venous and arterial vessels of the forearms or systemic vascular diseases.

• Pregnancy and/or breast-feeding.