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

NCT ID: NCT01313143

Last Updated: 2012-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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16 healthy volunteers of both sexes, age 18 to 45 years, will be enrolled. The mean dose necessary to suppress the Dobutamine induced heart rate increase of at least 30 bpm above baseline rate (maximum heart rate app. 110 bpm) by at least 20 bpm will be calculated for AOP200704 and Esmolol and the dose/efficacy relation of both agents to each other will be calculated for the steady state condition. For both drugs the time to reach a decrease of 10 bpm, 20 bpm and the maximum effect will be calculated. In addition the mean time to increase in 10 and 20 bpm and the time to reach maximum heart rate (increase of 30 bpm above baseline or more) after termination of infusion will also be assessed for both drugs. Blood pressure values will be compared for all above mentioned time points where heart rate is assessed for pharmacodynamics.The study will consist of a screening, cross-over 1, cross-over 2 and end-of-study visit.

Conditions

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Healthy Volunteers Pharmacokinetics/Dynamics Study

Keywords

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AOP200704, Esmolol, Pharmacokinetics, Pharmacodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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AOP200704, infusion

Group Type EXPERIMENTAL

AOP200704

Intervention Type DRUG

Comparison of AOP200704 with Esmolol

Esmolol, infusion

Group Type ACTIVE_COMPARATOR

Esmolol hydrochloride, infusion

Intervention Type DRUG

Comparison of AOP200704 with Esmolol

Interventions

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AOP200704

Comparison of AOP200704 with Esmolol

Intervention Type DRUG

Esmolol hydrochloride, infusion

Comparison of AOP200704 with Esmolol

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AOP Orphan Pharmaceuticals AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AOP Study Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

AOP Contract Clinical Research Facility

Locations

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AOP contract research facility

Pilsen, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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CPA368-10

Identifier Type: -

Identifier Source: org_study_id