AnaesthesiaPhase 1NCT01062867
First Administration to Man Of Org 25435 a New Intravenous Anesthetic
A Phase 1 study testing ORG25435 in people with Anaesthesia, run by University of Plymouth at 2 sites in United Kingdom.
Trial summary
Title: First administration to man of Org 25435, a new intravenous anaesthetic. Protocol: 12.4.104 Clinical Phase: Phase I Study Site: Phase I Clinical Trials Unit Ltd Old Convent of Notre Dame 119 Looseleigh Lane Plymouth PL6 5HH United Kingdom Objectives: To assess the safety, tolerability, preliminary… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anaesthesia
- What is being tested?
- ORG25435
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2000to Mar 2000
- Phase
- Phase 1
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good physical and mental health:
- Absence of a clinically relevant medical history
- Clinically acceptable hematology and clinical chemistry results
- Hemoglobin > 13.5 g/dl
- Normal ECG
- Diastolic blood pressure 60 to 90 mmHg inclusive
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- Normal cardiac morphology demonstrated by echocardiography
- Satisfactory cardiovascular response to exercise, measured by the Bruce Protocol, subjects must have completed Bruce stage 5
- Aged 18 to 35 years inclusive
- Body mass index (BMI) 19 to 27 inclusive, weight 65 to 100 kg inclusive
- Negative hepatitis screen
- Non-smoker for at least 6 months
- Previous experience of general anesthesia with no problems reported -
- Willingness to give written informed consent
- Ability to communicate well with the Investigators.
Who cannot join
- Females
- History or evidence of clinically significant cardiovascular, respiratory, endocrine, renal, hepatic, neurological or psychiatric disease.
- History of or familial presence of malignant hyperthermia.
- Presence of any condition likely to affect the normal kinetics of the study drug.
- Requirement for prescribed medication.
- Use of concomitant medication in the 5 days prior to dosing.
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- General anaesthesia within the previous 3 months.
- History of clinically significant allergy or hypersensitivity to any drug.
- History of clinically significant head injury.
- History of febrile convulsion.
- Known history of human immunodeficiency virus (HIV) infection.
- Use of investigational drug within previous three months.
- Previous administration of an investigational intravenous anaesthetic drug.
- Previous administration of Org 25435 within this study.
- History of alcohol / drug abuse.
- Average consumption of more than 20 units of alcohol a week.
- Subjects who smoke or who have smoked within the past 6 months.
- Inability to communicate with the Investigators for any reason.
- Donation of blood within one month of the study, or the intention to donate blood within one month following the study.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Phase 1 Clinical Trials
Plymouth, Devon
Phase 1 Clinical Trials Ltd
Plymouth
About this study
Title: First administration to man of Org 25435, a new intravenous anaesthetic.
Protocol: 12.4.104
Read more
Clinical Phase: Phase I
Study Site:
Phase I Clinical Trials Unit Ltd Old Convent of Notre Dame 119 Looseleigh Lane Plymouth PL6 5HH United Kingdom
Objectives: To assess the safety, tolerability, preliminary pharmacokinetics and efficacy of Org 25435 as an intravenous anaesthetic.
Study Design: Sequential study of an intravenous anaesthetic in young healthy males, at up to eight dose levels.
Study Drug: Org 25435, a water soluble intravenous anaesthetic.
Subjects: Up to 47 healthy male volunteers, aged 18-40 years.
Evaluations: Tolerability, adverse events, EEG effects, cardiovascular effects, electrocardiogram (ECG), excitatory phenomena, respiratory effects, laboratory safety blood analyses, pharmacodynamic and pharmacokinetic measurements.
Read the detailed description
Synopsis Trial Number 12.4.104 Trial Title First administration to man of Org 25435 a new intravenous anesthetic Trial Center Phase 1 Clinical Trials Unit Limited, 119 Looseleigh Lane, Derriford, Plymouth PL6 5HH Publication Studied Period The first subject was screened on 04/01/2000 and the final subject completed the follow up on 24/03/2000.
Phase of Development Phase I (First into Man) Objectives To assess the safety, tolerability and efficacy of Org 25435 as an intravenous anesthetic and to obtain preliminary pharmacodynamic and pharmacokinetic details of Org 25435.
Methodology Sequential rising dose study of an intravenous anesthetic in young healthy males, at up to eight dose levels.
Number of Subjects 19 healthy male volunteers were included into the dose escalation part of the study and an additional 7 volunteers participated in the Target Controlled Infusion (TCI) part of the study.
Diagnosis and Main Criteria for Inclusion Inclusion criteria:
Good physical and mental health: absence of a clinically relevant medical history; Clinically acceptable hematology and clinical chemistry results; Hemoglobin > 13.5 g/dl; Normal ECG; Diastolic blood pressure 60 to 90 mmHg inclusive; Normal cardiac morphology demonstrated by echocardiography; Satisfactory cardiovascular response to exercise, measured by the Bruce Protocol, subjects must have completed Bruce stage 5; Aged 18 to 35 years inclusive; Body mass index (BMI) 19 to 27 inclusive, weight 65 to 100 kg inclusive; Negative hepatitis screen; Non-smoker for at least 6 months; Previous experience of general anesthesia with no problems reported; Willingness to give written informed consent; Ability to communicate well with the Investigators.
Investigational Product Dose Mode of Administration Batch Number 1 vial 200mg Org 25435 / 10ml solvent for reconstitution Intended doses: 0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 5.0 and 6.0 mg/kg Intravenous 9J521 Duration of Treatment
Dose Escalation phase:
Each study treatment consisted of an intravenous infusion of Org 25435, given by Infusion pump over exactly 1 minute.
Target Controlled Infusion phase:
Each study treatment consisted of an intravenous infusion of Org25435 given by a computer-controlled infusion over 30 minutes.
Criteria for Evaluation Tolerability, adverse events, EEG effects, cardiovascular effects, electrocardiogram (ECG), excitatory phenomena, respiratory effects, laboratory safety blood analyses, pharmacodynamic and pharmacokinetic measurements. Efficacy Induction phenomena; time of cessation of speech, eye closure, loss of eyelash reflex, eyes open on command, limb movement on command and syringe drop. Other Induction phenomena; pain on injection, sign of histamine release, excitatory phenomena, respiratory depression, apnea. Recovery phenomena; nausea / vomiting, delirium, shivering, disturbed psychomotor function, eye opening on command, spontaneous respiration, adequate respiration, move limbs on command, increased saliva production.
Statistical Methods Formal statistical methods are not appropriate in this small pilot investigative study where group sizes comprise 5 or less subjects. All data collected is presented and summarized according to investigation type (Dose Escalation or TCI).
- Conditions
- Anaesthesia
- Being tested
- ORG25435
- Keywords
- Anaesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORG25435Drug
Also called ORG 25435
Intended doses: 0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 5.0 and 6.0 mg/kg by intravenous infusion over 1 min Up to 25mg/kg by infusion over 30min
| Study group | Role | What they receive |
|---|---|---|
| ORG25435 | Experimental | Infusion of intravenous anaesthetic agent to induce anaesthesia Receives: Drug: ORG25435 |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction of anaesthesia (loss of consciousness)
Measured: At time of drug administration. Recorded in minutes and seconds from the commencement of infusion.
Secondary outcomes (1)
recovery from anaesthesia (obey verbal commands)
Measured: At time of drug administration. Recorded as min and sec from end of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJan 2000
- Primary completionMar 2000
- Study completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaesthesiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Collaborators
- Veeda Clinical Research, Organon Teknika
- Investigators
- Robert Sneyd, MD, Study chair, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062867
- Sponsor's protocol ID
- CT 12.4.104
- Status last verified
- Jan 2010
- First submitted
- 2 Feb 2010
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Administration to Man Of Org 25435 a New Intravenous Anesthetic
- ClinicalTrials.gov ID
- NCT01062867
- Acronym / sponsor ID
- CT 12.4.104
- Conditions
- Anaesthesia
- Keywords
- Anaesthetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Collaborators
- Veeda Clinical Research, Organon Teknika
- Study start
- Jan 2000
- Primary completion
- Mar 2000 (actual)
- Study completion
- Mar 2000 (actual)
- First posted
- 4 Feb 2010 (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.
Title: First administration to man of Org 25435, a new intravenous anaesthetic.
Protocol: 12.4.104
Clinical Phase: Phase I
Study Site:
Phase I Clinical Trials Unit Ltd Old Convent of Notre Dame 119 Looseleigh Lane Plymouth PL6 5HH United Kingdom
Objectives: To assess the safety, tolerability, preliminary pharmacokinetics and efficacy of Org 25435 as an intravenous anaesthetic.
Study Design: Sequential study of an intravenous anaesthetic in young healthy males, at up to eight dose levels.
Study Drug: Org 25435, a water soluble intravenous anaesthetic.
Subjects: Up to 47 healthy male volunteers, aged 18-40 years.
Evaluations: Tolerability, adverse events, EEG effects, cardiovascular effects, electrocardiogram (ECG), excitatory phenomena, respiratory effects, laboratory safety blood analyses, pharmacodynamic and pharmacokinetic measurements.
Detailed description
Synopsis Trial Number 12.4.104 Trial Title First administration to man of Org 25435 a new intravenous anesthetic Trial Center Phase 1 Clinical Trials Unit Limited, 119 Looseleigh Lane, Derriford, Plymouth PL6 5HH Publication Studied Period The first subject was screened on 04/01/2000 and the final subject completed the follow up on 24/03/2000.
Phase of Development Phase I (First into Man) Objectives To assess the safety, tolerability and efficacy of Org 25435 as an intravenous anesthetic and to obtain preliminary pharmacodynamic and pharmacokinetic details of Org 25435.
Methodology Sequential rising dose study of an intravenous anesthetic in young healthy males, at up to eight dose levels.
Number of Subjects 19 healthy male volunteers were included into the dose escalation part of the study and an additional 7 volunteers participated in the Target Controlled Infusion (TCI) part of the study.
Diagnosis and Main Criteria for Inclusion Inclusion criteria:
Good physical and mental health: absence of a clinically relevant medical history; Clinically acceptable hematology and clinical chemistry results; Hemoglobin > 13.5 g/dl; Normal ECG; Diastolic blood pressure 60 to 90 mmHg inclusive; Normal cardiac morphology demonstrated by echocardiography; Satisfactory cardiovascular response to exercise, measured by the Bruce Protocol, subjects must have completed Bruce stage 5; Aged 18 to 35 years inclusive; Body mass index (BMI) 19 to 27 inclusive, weight 65 to 100 kg inclusive; Negative hepatitis screen; Non-smoker for at least 6 months; Previous experience of general anesthesia with no problems reported; Willingness to give written informed consent; Ability to communicate well with the Investigators.
Investigational Product Dose Mode of Administration Batch Number 1 vial 200mg Org 25435 / 10ml solvent for reconstitution Intended doses: 0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 5.0 and 6.0 mg/kg Intravenous 9J521 Duration of Treatment
Dose Escalation phase:
Each study treatment consisted of an intravenous infusion of Org 25435, given by Infusion pump over exactly 1 minute.
Target Controlled Infusion phase:
Each study treatment consisted of an intravenous infusion of Org25435 given by a computer-controlled infusion over 30 minutes.
Criteria for Evaluation Tolerability, adverse events, EEG effects, cardiovascular effects, electrocardiogram (ECG), excitatory phenomena, respiratory effects, laboratory safety blood analyses, pharmacodynamic and pharmacokinetic measurements. Efficacy Induction phenomena; time of cessation of speech, eye closure, loss of eyelash reflex, eyes open on command, limb movement on command and syringe drop. Other Induction phenomena; pain on injection, sign of histamine release, excitatory phenomena, respiratory depression, apnea. Recovery phenomena; nausea / vomiting, delirium, shivering, disturbed psychomotor function, eye opening on command, spontaneous respiration, adequate respiration, move limbs on command, increased saliva production.
Statistical Methods Formal statistical methods are not appropriate in this small pilot investigative study where group sizes comprise 5 or less subjects. All data collected is presented and summarized according to investigation type (Dose Escalation or TCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ORG25435 | Experimental | Drug: ORG25435Infusion of intravenous anaesthetic agent to induce anaesthesia |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Good physical and mental health:
- Absence of a clinically relevant medical history
- Clinically acceptable hematology and clinical chemistry results
- Hemoglobin > 13.5 g/dl
- Normal ECG
Key exclusion criteria (19 listed)
- Females
- History or evidence of clinically significant cardiovascular, respiratory, endocrine, renal, hepatic, neurological or psychiatric disease.
- History of or familial presence of malignant hyperthermia.
- Presence of any condition likely to affect the normal kinetics of the study drug.
- Requirement for prescribed medication.
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 |
|---|---|---|
| ORG25435Also: ORG 25435Intended doses: 0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 5.0 and 6.0 mg/kg by intravenous infusion over 1 min Up to 25mg/kg by infusion over 30min | Drug | ORG25435 |
Primary outcome
induction of anaesthesia (loss of consciousness)
Time frame: At time of drug administration. Recorded in minutes and seconds from the commencement of infusion.
1 secondary outcome
recovery from anaesthesia (obey verbal commands)
Time frame: At time of drug administration. Recorded as min and sec from end of infusion
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 4 Feb 2010.
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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.
Robert Sneyd, MD study chair
University of Plymouth
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ORG25435 in people with Anaesthesia, run by University of Plymouth at 2 sites in United Kingdom.
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 15 inclusion and 19 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 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
induction of anaesthesia (loss of consciousness) (time frame: At time of drug administration. Recorded in minutes and seconds from the commencement of infusion.). 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 4 Feb 2010.