Healthy VolunteersPhase 2NCT01313143
A Short Term Pharmacokinetic, Pharmacodynamic and Tolerability Study to Compare AOP200704 vs. Esmolol
A Phase 2 study testing AOP200704 and Esmolol hydrochloride, infusion in people with Healthy Volunteers and Pharmacokinetics/Dynamics Study, run by AOP Orphan Pharmaceuticals AG at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Pharmacokinetics/Dynamics Study
- What is being tested?
- AOP200704 and Esmolol hydrochloride, infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCzechia
- Study dates
- Mar 2011to Jan 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Double Blinded, Crossover, Two-treatment, Two-sequence, Short Term Pharmacokinetic, Pharmacodynamic and Tolerability, Single Centre Study to Compare AOP200704 vs. Esmolol in Healthy Subjects.
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.
Read the detailed description
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.
- Being tested
- AOP200704, Esmolol hydrochloride, infusion
- Keywords
- AOP200704, Esmolol, Pharmacokinetics, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOP200704Drug
Comparison of AOP200704 with Esmolol
Esmolol hydrochloride, infusionDrug
Comparison of AOP200704 with Esmolol
| Study group | Role | What they receive |
|---|---|---|
| AOP200704, infusion | Experimental | Not described Receives: Drug: AOP200704 |
| Esmolol, infusion | Active comparator | Not described Receives: Drug: Esmolol hydrochloride, infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics/dynamics
Measured: 9 hours
Secondary outcomes (1)
Local tolerability
Measured: 9 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AOP Orphan Pharmaceuticals AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AOP Study Principal Investigator, Principal investigator, AOP Contract Clinical Research Facility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313143
- Sponsor's protocol ID
- CPA368-10
- Status last verified
- Jul 2012
- First submitted
- 10 Mar 2011
- Last updated
- 19 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double Blinded, Crossover, Two-treatment, Two-sequence, Short Term Pharmacokinetic, Pharmacodynamic and Tolerability, Single Centre Study to Compare AOP200704 vs. Esmolol in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT01313143
- Acronym / sponsor ID
- CPA368-10
- Keywords
- AOP200704, Esmolol, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AOP Orphan Pharmaceuticals AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AOP200704, infusion | Experimental | Drug: AOP200704 |
| Esmolol, infusion | Active comparator | Drug: Esmolol hydrochloride, infusion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AOP200704Comparison of AOP200704 with Esmolol | Drug | AOP200704, infusion |
| Esmolol hydrochloride, infusionComparison of AOP200704 with Esmolol | Drug | Esmolol, infusion |
Primary outcome
Pharmacokinetics/dynamics
Time frame: 9 hours
1 secondary outcome
Local tolerability
Time frame: 9 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AOP Study Principal Investigator principal investigator
AOP Contract Clinical Research Facility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AOP200704 and Esmolol hydrochloride, infusion in people with Healthy Volunteers and Pharmacokinetics/Dynamics Study, run by AOP Orphan Pharmaceuticals AG at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics/dynamics (time frame: 9 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2012.