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

NCT01313143 | Completed Phase 2

• 1 other identifier: CPA368-10
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers; Pharmacokinetics/Dynamics Study

Keywords

AOP200704, Esmolol, Pharmacokinetics, Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics/dynamics

  9 hours

Secondary Outcomes (1)

• Local tolerability

  9 hours

Study Arms (2)

AOP200704, infusion

EXPERIMENTAL

Drug: AOP200704

Esmolol, infusion

ACTIVE COMPARATOR

Drug: Esmolol hydrochloride, infusion

Interventions

AOP200704 DRUG

Comparison of AOP200704 with Esmolol

AOP200704, infusion

Esmolol hydrochloride, infusion DRUG

Comparison of AOP200704 with Esmolol

Esmolol, infusion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AOP Orphan Pharmaceuticals AG: lead

Study Sites (1)

AOP contract research facility

Pilsen, 32300, Czechia

Location

MeSH Terms

Interventions

esmolol

Study Officials

• AOP Study Principal Investigator

  AOP Contract Clinical Research Facility

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 11, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: January 1, 2012
• Last Updated: July 19, 2012

Record last verified: 2012-07

Locations

CZ (1)