HealthyPhase 1RopiCloBetNCT06781632
Phase I Study of Ropivacaine, Clonidine, and Betamethasone Combination for Sciatic Nerve Block in the Popliteal Region
A Phase 1 study testing ropivacaine in people with Healthy and Nerve Block, run by PHARMAFINA at 1 site in Turkey (Türkiye).
Trial summary
This is a national, single-center, dose-escalation Phase I study to investigate the safety, pharmacokinetics, and efficacy of a combination containing Ropivacaine, Clonidine, and Betamethasone (Ropiclobet) in healty volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Nerve Block
- What is being tested?
- ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2024to 25 Apr 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers based on the results of medical evaluation, including medical history, physical examination, neurological examination, laboratory tests, and cardiac monitoring, performed by the investigator.
- Between 18 and 45 years, male and female
- Provide a signed and dated written informed consent
- A negative pregnancy test at the screening visit for female volunteers with childbearing potential
- Negative alcohol breath test.
- Negative urine drug screening for addictive substances (amphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine, opioids).
- Capable of completing all tests and evaluations related to the study.
- In the investigator's opinion, the volunteer must have the potential to comply with the study requirements.
Who cannot join
- Volunteers with hypersensitivity to local anesthesia/regional anesthesia.
- Volunteers with a known hypersensitivity to amide-based local anesthetics.
- Volunteers with chronic pain.
- Volunteers with neuromuscular diseases or peripheral neuropathy.
- Volunteers with bleeding disorders/coagulopathies.
- Volunteers with a history of motor or sensory loss in the lower extremities.
Show all 21Show fewer
- Volunteers with a history of arrhythmia or seizures.
- Volunteers with renal or hepatic insufficiency.
- Volunteers diagnosed with diabetes.
- Volunteers with hereditary neuropathy.
- Volunteers with a body mass index (BMI) > 35 kg/m².
- Pregnant, breastfeeding, or women with a positive pregnancy test.
- Volunteers with skin infections or wounds at the injection site.
- Volunteers with clinically significant abnormalities in the ECG, such as rhythm, conduction, or morphology issues, or any abnormalities on a 12-lead ECG that could interfere with the interpretation of QTc interval changes (including normal ST-T wave morphology or left ventricular hypertrophy), as determined by the investigator or medical monitor, or those on chronic use of antiarrhythmic medications.
- Volunteers with clinically significant abnormalities in vital signs during screening, which may include:
- systolic blood pressure < 90 or > 140 mmHg,
- diastolic blood pressure < 50 or > 95 mmHg,
- heart rate < 45 or > 100 beats/min, measured three times at 5-minute intervals in a seated position.
- Volunteers with any condition (medical, psychological, social, etc.) that may impair their ability to comply with the study, as assessed by the investigator.
- Volunteers currently participating in another clinical study.
- Volunteers with a positive urine drug screening and/or alcohol test.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine Phase I and Clinical Research Center
Istanbul, 34093
About this study
Official title: Phase I Study Evaluating Safety, Pharmacokinetics, and Efficacy of a Combination Containing Ropivacaine, Clonidine, and Betamethasone (Ropiclobet, Batch:PL23001) for Sciatic Nerve Block in the Popliteal Region in Healthy Volunteers
This is a national, single-center, dose-escalation Phase I study to investigate the safety, pharmacokinetics, and efficacy of a combination containing Ropivacaine, Clonidine, and Betamethasone (Ropiclobet) in healty volunteers.
After screening and eligibility confirmation, at least 28 participants will receive a sciatic nerve block in the popliteal region with Ropiclobet, followed by pharmacokinetic assessments through blood sampling and monitoring of motor and sensory nerve blocks in the tibial and common peroneal nerves. Safety evaluations, including physical exams, vital signs, ECGs, and sedation scores, will be conducted throughout the study. sensory blocks resolve.
Read more
Participants will remain under observation for 48 hours post-procedure and will be discharged once motor and sensory blocks resolve. Follow-up visits will be conducted on Days 10 and 15 on an outpatient basis, with an end-of-study visit planned for Day 30.
The dose-escalation protocol involves administering 5 mL, 10 mL, 15 mL, and 20 mL doses to sequential groups of participants, with safety assessments performed after each dose level before proceeding.
Read the detailed description
This is a national, single-center, dose-escalation Phase I clinical study designed to evaluate the safety, pharmacokinetics, and efficacy of a novel combination drug containing Ropivacaine, Clonidine, and Betamethasone, referred to as Ropiclobet, in healthy adult volunteers. The primary objective is to assess the safety of Ropiclobet when administered as a sciatic nerve block in the popliteal region. Secondary objectives include monitoring the drug's efficacy in inducing motor and sensory nerve blockade and evaluating its pharmacokinetic profile through.
The study will begin with the enrollment of a minimum of 28 healthy volunteers who meet the predefined eligibility criteria. Once deemed eligible, participants will receive a sciatic nerve block in the popliteal region using the investigational combination drug Ropiclobet. To investigate the pharmacokinetics of Ropiclobet, blood samples will be collected from each volunteer at carefully scheduled time points post-administration. These samples will be analyzed to determine the plasma concentrations of the three active components: Ropivacaine, Clonidine, and Betamethasone. Concurrently, effects of the drug will be evaluated by monitoring motor and sensory nerve blockades, specifically targeting the two primary branches of the popliteal nerve: the tibial nerve and the common peroneal nerve. Sensory blockade assessments will include tests for pin-prick and temperature sensations, while motor block evaluation will involve standardized clinical examinations.
Throughout the study, comprehensive safety monitoring will be conducted. This includes regular physical examinations, continuous vital sign measurements, electrocardiograms (ECGs), and the assessment of sedation levels. Volunteers will remain under observation in the Phase I clinic for at least 48 hours post-procedure. Discharge from the clinic will only occur after confirmation that both motor and sensory blocks have fully resolved. If the blocks persist beyond the 48-hour observation window, participants will be discharged no later than six hours following the resolution of the blockades. In addition to in-clinic assessments, follow-up evaluations will be performed on Days 10 and 15 on an outpatient basis, with a comprehensive end-of-study visit scheduled for Day 30. These visits aim to identify any delayed adverse effects and to ensure the complete recovery of participants.
The study's dose-escalation protocol involves four predefined dose levels of Ropiclobet: 5 mL, 10 mL, 15 mL, and 20 mL. Initially, 4 volunteers will receive a 5 mL dose for the sciatic nerve block. After a 48-hour observation period, detailed safety assessments will determine whether it is safe to proceed to the next dose level. If the safety profile of the 5 mL dose is deemed acceptable, an additional 8 volunteers will receive a 10 mL dose. This stepwise approach will continue with escalating doses of 15 mL and 20 mL, with safety evaluations conducted at each level before advancing to the subsequent dose. The final dose of 20 mL will only be administered if safety parameters remain within acceptable limits throughout the study.
- Conditions
- Healthy, Nerve Block
- Being tested
- ropivacaine
- Keywords
- Ropivacaine, Clonidine, Betamethasone, Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
Also called clonidine, betamethasone
Ropivacaine HCl - Betamethasone Sodium Phosphate - Clonidine HCl 5.0/0.4*/0.015 mg/mL (The solution contains 0.53 mg of betamethasone sodium phosphate, equivalent to 0.4 mg of betamethasone)
| Study group | Role | What they receive |
|---|---|---|
| Nerve Block Arm | Experimental | Volunteers will undergo sciatic nerve block in the popliteal region using the combination drug Ropiclobet (Ropivacaine-Clonidine-Betamethasone) Receives: Drug: ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-related adverse events assessed by NCI-CTCAE
The incidence of treatment-related adverse events, measured according to NCI-CTCAE criteria.
Measured: From nerve block procedure to the end of study visit at 30 days
Number of treatment-related adverse events assessed by laboratory parameters
The incidence of treatment-related adverse events based on hematological, and biochemical parameters
Measured: Before nerve block procedure, 24 and 48 hours after procedure, and during follow-up visits on Day 10, Day 15, Day 30
Number of treatment-related adverse events assessed by ECG
The incidence of treatment-related adverse events based on electrocardiography
Measured: From nerve block procedure to discharge at 48 hours, and during follow-up visits on Day 10, Day 15, Day 30
Number of treatment-related adverse events assessed by physical examination and vital signs
The incidence of treatment-related adverse events based on physical examination and vital signs
Measured: From nerve block procedure to discharge at 48 hours, and during follow-up visits on Day 10, Day 15, Day 30
Secondary outcomes (8)
Pharmacokinetics (concentration analysis)
The concentration-time profiles in plasma for each of the three active ingredients (Cmax)
Measured: before the sciatic nerve block (at 0.hour) and post-block at 15, 30, and 45 minutes, and at 1, 2, 3, 4, 6, 8, 12, 18, 24, and 48 hours.
Pharmacokinetics (concentration analysis)
The concentration-time profiles in plasma for each of the three active ingredients (Area under curve)
Measured: before the sciatic nerve block (at 0.hour) and post-block at 15, 30, and 45 minutes, and at 1, 2, 3, 4, 6, 8, 12, 18, 24, and 48 hours.
Pharmacokinetics (concentration analysis)
The concentration-time profiles in plasma for each of the three active ingredients (tmax)
Measured: before the sciatic nerve block (at 0.hour) and post-block at 15, 30, and 45 minutes, and at 1, 2, 3, 4, 6, 8, 12, 18, 24, and 48 hours.
Efficacy of ropiclobet assessed by onset of motor block
The time to the onset of complete motor block (in minutes or hours)
Measured: From nerve block procedure to the onset of motor block, up to 48 hours
Efficacy of ropiclobet assessed by duration of motor block
The time of resolution of the motor block (in minutes or hours)
Measured: From nerve block procedure to the resolution of the motor block, up to 48 hours
Efficacy of ropiclobet assessed by onset of sensorial block
The time to the onset of complete sensorial block (in minutes or hours)
Measured: From nerve block procedure to the onset of sensorial block, up to 48 hours
Efficacy of ropiclobet assessed by duration of sensorial block
The time of resolution of the sensorial block (in minutes or hours)
Measured: From nerve block procedure to the resolution of the sensorial block, up to 48 hours
Efficacy ropiclobet assessed by duration of motor and sensorial block
Total motor and sensorial block time (in minutes or hours)
Measured: From onset of motor and sensorial block to the resolution, up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start13 Nov 2024
- Primary completion20 Feb 2025
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- PHARMAFINA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MonitorCRO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781632
- Sponsor's protocol ID
- PF_001
- Acronym
- RopiCloBet
- Status last verified
- May 2025
- First submitted
- 6 Jan 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Evaluating Safety, Pharmacokinetics, and Efficacy of a Combination Containing Ropivacaine, Clonidine, and Betamethasone (Ropiclobet, Batch:PL23001) for Sciatic Nerve Block in the Popliteal Region in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06781632
- Acronym / sponsor ID
- RopiCloBet / PF_001
- Conditions
- Healthy, Nerve Block
- Keywords
- Ropivacaine, Clonidine, Betamethasone, Nerve Block
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PHARMAFINAIndustry (pharma, biotech, devices)
- Collaborators
- MonitorCRO
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 17 Jan 2025 (actual)
- 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.
This is a national, single-center, dose-escalation Phase I study to investigate the safety, pharmacokinetics, and efficacy of a combination containing Ropivacaine, Clonidine, and Betamethasone (Ropiclobet) in healty volunteers.
After screening and eligibility confirmation, at least 28 participants will receive a sciatic nerve block in the popliteal region with Ropiclobet, followed by pharmacokinetic assessments through blood sampling and monitoring of motor and sensory nerve blocks in the tibial and common peroneal nerves. Safety evaluations, including physical exams, vital signs, ECGs, and sedation scores, will be conducted throughout the study. sensory blocks resolve.
Participants will remain under observation for 48 hours post-procedure and will be discharged once motor and sensory blocks resolve. Follow-up visits will be conducted on Days 10 and 15 on an outpatient basis, with an end-of-study visit planned for Day 30.
The dose-escalation protocol involves administering 5 mL, 10 mL, 15 mL, and 20 mL doses to sequential groups of participants, with safety assessments performed after each dose level before proceeding.
Detailed description
This is a national, single-center, dose-escalation Phase I clinical study designed to evaluate the safety, pharmacokinetics, and efficacy of a novel combination drug containing Ropivacaine, Clonidine, and Betamethasone, referred to as Ropiclobet, in healthy adult volunteers. The primary objective is to assess the safety of Ropiclobet when administered as a sciatic nerve block in the popliteal region. Secondary objectives include monitoring the drug's efficacy in inducing motor and sensory nerve blockade and evaluating its pharmacokinetic profile through.
The study will begin with the enrollment of a minimum of 28 healthy volunteers who meet the predefined eligibility criteria. Once deemed eligible, participants will receive a sciatic nerve block in the popliteal region using the investigational combination drug Ropiclobet. To investigate the pharmacokinetics of Ropiclobet, blood samples will be collected from each volunteer at carefully scheduled time points post-administration. These samples will be analyzed to determine the plasma concentrations of the three active components: Ropivacaine, Clonidine, and Betamethasone. Concurrently, effects of the drug will be evaluated by monitoring motor and sensory nerve blockades, specifically targeting the two primary branches of the popliteal nerve: the tibial nerve and the common peroneal nerve. Sensory blockade assessments will include tests for pin-prick and temperature sensations, while motor block evaluation will involve standardized clinical examinations.
Throughout the study, comprehensive safety monitoring will be conducted. This includes regular physical examinations, continuous vital sign measurements, electrocardiograms (ECGs), and the assessment of sedation levels. Volunteers will remain under observation in the Phase I clinic for at least 48 hours post-procedure. Discharge from the clinic will only occur after confirmation that both motor and sensory blocks have fully resolved. If the blocks persist beyond the 48-hour observation window, participants will be discharged no later than six hours following the resolution of the blockades. In addition to in-clinic assessments, follow-up evaluations will be performed on Days 10 and 15 on an outpatient basis, with a comprehensive end-of-study visit scheduled for Day 30. These visits aim to identify any delayed adverse effects and to ensure the complete recovery of participants.
The study's dose-escalation protocol involves four predefined dose levels of Ropiclobet: 5 mL, 10 mL, 15 mL, and 20 mL. Initially, 4 volunteers will receive a 5 mL dose for the sciatic nerve block. After a 48-hour observation period, detailed safety assessments will determine whether it is safe to proceed to the next dose level. If the safety profile of the 5 mL dose is deemed acceptable, an additional 8 volunteers will receive a 10 mL dose. This stepwise approach will continue with escalating doses of 15 mL and 20 mL, with safety evaluations conducted at each level before advancing to the subsequent dose. The final dose of 20 mL will only be administered if safety parameters remain within acceptable limits throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerve Block Arm | Experimental | Drug: ropivacaineVolunteers will undergo sciatic nerve block in the popliteal region using the combination drug Ropiclobet (Ropivacaine-Clonidine-Betamethasone) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy volunteers based on the results of medical evaluation, including medical history, physical examination, neurological examination, laboratory tests, and cardiac monitoring, performed by the investigator.
- Between 18 and 45 years, male and female
- Provide a signed and dated written informed consent
- A negative pregnancy test at the screening visit for female volunteers with childbearing potential
- Negative alcohol breath test.
Key exclusion criteria (21 listed)
- Volunteers with hypersensitivity to local anesthesia/regional anesthesia.
- Volunteers with a known hypersensitivity to amide-based local anesthetics.
- Volunteers with chronic pain.
- Volunteers with neuromuscular diseases or peripheral neuropathy.
- Volunteers with bleeding disorders/coagulopathies.
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 |
|---|---|---|
| ropivacaineAlso: clonidine, betamethasoneRopivacaine HCl - Betamethasone Sodium Phosphate - Clonidine HCl 5.0/0.4*/0.015 mg/mL (The solution contains 0.53 mg of betamethasone sodium phosphate, equivalent to 0.4 mg of betamethasone) | Drug | Nerve Block Arm |
Primary outcome
Number of treatment-related adverse events assessed by NCI-CTCAE
Time frame: From nerve block procedure to the end of study visit at 30 days
The incidence of treatment-related adverse events, measured according to NCI-CTCAE criteria.
Number of treatment-related adverse events assessed by laboratory parameters
Time frame: Before nerve block procedure, 24 and 48 hours after procedure, and during follow-up visits on Day 10, Day 15, Day 30
The incidence of treatment-related adverse events based on hematological, and biochemical parameters
Number of treatment-related adverse events assessed by ECG
Time frame: From nerve block procedure to discharge at 48 hours, and during follow-up visits on Day 10, Day 15, Day 30
The incidence of treatment-related adverse events based on electrocardiography
Number of treatment-related adverse events assessed by physical examination and vital signs
Time frame: From nerve block procedure to discharge at 48 hours, and during follow-up visits on Day 10, Day 15, Day 30
The incidence of treatment-related adverse events based on physical examination and vital signs
8 secondary outcomes
Pharmacokinetics (concentration analysis)
Time frame: before the sciatic nerve block (at 0.hour) and post-block at 15, 30, and 45 minutes, and at 1, 2, 3, 4, 6, 8, 12, 18, 24, and 48 hours.
Pharmacokinetics (concentration analysis)
Time frame: before the sciatic nerve block (at 0.hour) and post-block at 15, 30, and 45 minutes, and at 1, 2, 3, 4, 6, 8, 12, 18, 24, and 48 hours.
Pharmacokinetics (concentration analysis)
Time frame: before the sciatic nerve block (at 0.hour) and post-block at 15, 30, and 45 minutes, and at 1, 2, 3, 4, 6, 8, 12, 18, 24, and 48 hours.
Efficacy of ropiclobet assessed by onset of motor block
Time frame: From nerve block procedure to the onset of motor block, up to 48 hours
Efficacy of ropiclobet assessed by duration of motor block
Time frame: From nerve block procedure to the resolution of the motor block, up to 48 hours
Efficacy of ropiclobet assessed by onset of sensorial block
Time frame: From nerve block procedure to the onset of sensorial block, up to 48 hours
Efficacy of ropiclobet assessed by duration of sensorial block
Time frame: From nerve block procedure to the resolution of the sensorial block, up to 48 hours
Efficacy ropiclobet assessed by duration of motor and sensorial block
Time frame: From onset of motor and sensorial block to the resolution, up to 48 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 18 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ropivacaine in people with Healthy and Nerve Block, run by PHARMAFINA at 1 site in Turkey (Türkiye).
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 8 inclusion and 21 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 18 May 2025. 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 Turkey (Türkiye). 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?
Number of treatment-related adverse events assessed by NCI-CTCAE (time frame: From nerve block procedure to the end of study visit at 30 days). The study lists 4 primary outcomes in all. 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 18 May 2025.