SeizuresPhase 1NCT02332174
Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects
A Phase 1 study testing rufinamide in people with Seizures, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
The purpose of this study was to determine the pharmacokinetic (PK) and safety profile of single and multiple doses of rufinamide. The effects of food and sex on the PK properties of rufinamide in these Chinese volunteers were also evaluated. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Seizures
- What is being tested?
- rufinamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jun 2014
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index between19 and 24 kg/m2
- negative for HIV and hepatitis B
- had no clinicallyimportant findings on health tests
- thorax radiography and ECG with no abnormalities
- normal blood pressure values
- heart rate
Who cannot join
- any drug treatment within 2 weeks before starting the study
- participation in another clinical study within the previous 3 months
- alcoholism and smoking
- pregnancy
- breast-feeding
- hypocalcemia
Show all 9Show fewer
- blood donation or participation in other clinical trials within 3 months before enrollment in the study
- sitting blood pressure <80/50 mm Hg or >140/100 mm Hg
- A ventricular rate <60 beats/min or >100 beats/min at rest
About this study
Official title: Pharmacokinetics and Tolerability of Rufinamide Following Single and Multiple Oral Doses and Effect of Food on Pharmacokinetics in Healthy Chinese Subjects
The purpose of this study was to determine the pharmacokinetic (PK) and safety profile of single and multiple doses of rufinamide. The effects of food and sex on the PK properties of rufinamide in these Chinese volunteers were also evaluated.
Read the detailed description
This single- and multiple-dose, randomized, open-label study was conducted in healthy Chinese subjects. In the single-dose study, volunteers were randomly assigned to 4 dose groups and received a single dose of 200, 400, 800, 1200 mg rufinamide tablets under fasted condition. An additional food effect study was performed in the 200-mg dose group by assessing changes in PK parameters after high-fat diet. In the multiple-dose study, 10 subjects were administered 200-mg rufinamide formulation twice daily for 6 consecutive days. LC-MS/MS method was applied to determine plasma concentration of rufinamide. Tolerability was assessed based on investigator inquiries, spontaneous reports, and clinical evaluations such as standard laboratory tests, vital signs, physical examinations and 12-lead electrocardiography.
- Conditions
- Seizures
- Being tested
- rufinamide
- Keywords
- pharmacokinetics, food effect, sex effect, tolerability
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rufinamideDrug
Also called 106308-44-5
comparison of different doses, sex and medication conditions
| Study group | Role | What they receive |
|---|---|---|
| 200-mg group | Experimental | Ten healthy subjects were administered a single oral dose of 200 mg rufinamide tablets in fasted and fed state at day 1 and then received repeated oral doses of rufinamide (200 mg) once daily for 6 days. Receives: Drug: rufinamide |
| 400-mg group | Experimental | Ten healthy subjects were administered a single oral dose of 400 mg rufinamide tablets in fasted state. Receives: Drug: rufinamide |
| 800-mg group | Experimental | Ten healthy subjects were administered a single oral dose of 800 mg rufinamide tablets in fasted state. Receives: Drug: rufinamide |
| 1200-mg group | Experimental | Ten healthy subjects were administered a single oral dose of 1200 mg rufinamide tablets in fasted state. Receives: Drug: rufinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
the area under the concentration-time curve
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startMar 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiyong Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Weiyong Li, PhD, Principal investigator, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332174
- Sponsor's protocol ID
- TJXH-Rufi
- Status last verified
- Jan 2015
- First submitted
- 3 Jan 2015
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Tolerability of Rufinamide Following Single and Multiple Oral Doses and Effect of Food on Pharmacokinetics in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT02332174
- Acronym / sponsor ID
- TJXH-Rufi
- Conditions
- Seizures
- Keywords
- pharmacokinetics, food effect, sex effect, tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 Jan 2015 (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.
The purpose of this study was to determine the pharmacokinetic (PK) and safety profile of single and multiple doses of rufinamide. The effects of food and sex on the PK properties of rufinamide in these Chinese volunteers were also evaluated.
Detailed description
This single- and multiple-dose, randomized, open-label study was conducted in healthy Chinese subjects. In the single-dose study, volunteers were randomly assigned to 4 dose groups and received a single dose of 200, 400, 800, 1200 mg rufinamide tablets under fasted condition. An additional food effect study was performed in the 200-mg dose group by assessing changes in PK parameters after high-fat diet. In the multiple-dose study, 10 subjects were administered 200-mg rufinamide formulation twice daily for 6 consecutive days. LC-MS/MS method was applied to determine plasma concentration of rufinamide. Tolerability was assessed based on investigator inquiries, spontaneous reports, and clinical evaluations such as standard laboratory tests, vital signs, physical examinations and 12-lead electrocardiography.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 200-mg group | Experimental | Drug: rufinamideTen healthy subjects were administered a single oral dose of 200 mg rufinamide tablets in fasted and fed state at day 1 and then received repeated oral doses of rufinamide (200 mg) once daily for 6 days. |
| 400-mg group | Experimental | Drug: rufinamideTen healthy subjects were administered a single oral dose of 400 mg rufinamide tablets in fasted state. |
| 800-mg group | Experimental | Drug: rufinamideTen healthy subjects were administered a single oral dose of 800 mg rufinamide tablets in fasted state. |
| 1200-mg group | Experimental | Drug: rufinamideTen healthy subjects were administered a single oral dose of 1200 mg rufinamide tablets in fasted state. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- body mass index between19 and 24 kg/m2
- negative for HIV and hepatitis B
- had no clinicallyimportant findings on health tests
- thorax radiography and ECG with no abnormalities
- normal blood pressure values
Key exclusion criteria (9 listed)
- any drug treatment within 2 weeks before starting the study
- participation in another clinical study within the previous 3 months
- alcoholism and smoking
- pregnancy
- breast-feeding
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 |
|---|---|---|
| rufinamideAlso: 106308-44-5comparison of different doses, sex and medication conditions | Drug | 1200-mg group, 200-mg group, 400-mg group, 800-mg group |
Primary outcome
AUC
Time frame: three days
the area under the concentration-time curve
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 6 Jan 2015.
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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.
Weiyong Li, PhD principal investigator
Tongji Medical College, Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rufinamide in people with Seizures, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 6 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 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
AUC (time frame: three days). 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 6 Jan 2015.