HealthyPhase 1NCT01215084
A Pharmacokinetics (PK) and Safety Study of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
A Phase 1 study testing BIIB041 (Fampridine-PR) in people with Healthy, run by Biogen at 2 sites in 2 countries.
Trial summary
The primary objective of the study is to determine the Pharmacokinetic (PK) and safety profiles of fampridine-PR 10 mg in Chinese and Japanese adult healthy volunteers. The secondary objective of this study is to compare the PK and safety profiles of fampridine-PR 10 mg among the Chinese, Japanese, and Caucasian adult… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIIB041 (Fampridine-PR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2010to Nov 2010
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Subjects of Chinese or Japanese origin (at least both maternal and paternal grandparents of Chinese or Japanese origin, respectively), or Caucasian subjects. Japanese subjects should be on Japanese diet on a regular basis.
- All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 weeks after their single dose of study treatment.
- Body Mass Index (BMI) within the range 18.5 to 30 kg/m2 (inclusive).
- Normal urinalysis results as determined by the Investigator for the following parameters: protein, glucose, specific gravity, ketones, urobilinogen, bilirubin, pH, and blood.
- Normal 12-lead ECG as determined by the Investigator.
Who cannot join
- Known history of human immunodeficiency virus (HIV) infection or positive test result for HIV antibodies.
- Known history of hepatitis B or hepatitis C infection, hepatitis B carrier (positive test result for Hepatitis B Surface Antigen [HBsAg]), or hepatitis C infection (positive test result for Hepatitis C virus antibody [HCV Ab]).
- Psychiatric or neurological disorders.
- History of epilepsy or other convulsive disorders.
- Any cardiovascular, renal, gastrointestinal, respiratory, metabolic disorder, or other major disease, as determined by the Investigator.
- Clinically significant abnormal hematology or blood chemistry values at Screening, as determined by the Investigator; or any screening values for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) that are 1.5 times greater than the upper limit of the normal; any clinically significant (as determined by the Investigator) elevated screening values for bilirubin or creatinine; creatinine clearance lower than 80 mL/minute; any low screening values for platelets or hemoglobin; or an out of normal range for white blood cells (WBC).
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- History of alcohol abuse (as defined by the Investigator) within the previous 2 years, or a blood screen positive for alcohol.
- History of drug abuse (as defined by the Investigator) within the previous 2 years, or a urine screen positive for cannabinoids, barbiturates, amphetamines, and benzodiazepines.
- Premalignant and malignant disease.
- History of clinically significant severe allergic or anaphylactic reactions.
- Known allergy to pyridine-containing substances.
- Active bacterial or viral infection within the previous month.
- Female subjects who are pregnant or currently breastfeeding.
- Previous participation in another investigational drug study within the last 3 months.
- Treatment with any prescription medication within the 28 days prior to Day -1. (Treatment with pharmaceutical-grade vitamins is allowed provided the dose and regimen have been stable for the 28 days prior to Day -1.)
- Treatment with any over-the-counter products, including herbal-containing and/or caffeine-containing preparations, and/or alternative health preparations and procedures within the 2 days prior to Day -1.
- Donation of blood (500 mL or greater) within 56 days prior to study dosing or plasma donation within 7 days prior to study dosing.
- Inability to comply with study requirements.
- Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Single-Dose, Open-Label, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
The primary objective of the study is to determine the Pharmacokinetic (PK) and safety profiles of fampridine-PR 10 mg in Chinese and Japanese adult healthy volunteers. The secondary objective of this study is to compare the PK and safety profiles of fampridine-PR 10 mg among the Chinese, Japanese, and Caucasian adult healthy volunteers.
Read the detailed description
The Caucasian group is included to allow comparison of pharmacokinetic and safety data from different race groups to be performed with data obtained from the same study under the same controlled conditions.
- Conditions
- Healthy
- Being tested
- BIIB041 (Fampridine-PR)
- Keywords
- Human Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB041 (Fampridine-PR)Drug
Also called AMPYRA®, Dalfampridine, FAMPYRA®
A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants
| Study group | Role | What they receive |
|---|---|---|
| Chinese Subpopulation: Fampridine-PR 10 mg | Experimental | Chinese ethnic participants were administered a single dose of Fampridine-PR 10 mgs Receives: Drug: BIIB041 (Fampridine-PR) |
| Japanese Subpopulation: Fampridine-PR 10mg | Experimental | Japanese ethnic participants were administered a single dose of Fampridine-PR 10 mgs Receives: Drug: BIIB041 (Fampridine-PR) |
| Caucasian Subpopulation: Fampridine-PR 10mg | Experimental | Caucasian ethnic participants were administered a single dose of Fampridine-PR 10 mgs Receives: Drug: BIIB041 (Fampridine-PR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with treatment-emergent adverse events in each ethnic group
Measured: Day 1 to Day 7
Observed maximum (peak) plasma 4-aminopyridine (4-AP) concentration (Cmax)
Measured: Day 1 (0 to 24 Hours After Dosing)
Time to reach Cmax following study treatment administration (Tmax)
Measured: Day 1 (0 to 24 Hours After Dosing)
Area under the time-concentration curve from time zero to infinity (AUC0-∞)
Measured: Day 1 (0 to 24 Hours After Dosing)
Apparent elimination half-life (T1/2)
Measured: Day 1 (0 to 24 Hours After Dosing)
Renal clearance of the drug from plasma
Measured: Day 1 (0 to 24 Hours After Dosing)
Renal clearance as a fraction of total clearance
Measured: Day 1 (0 to 24 Hours After Dosing)
Cumulative excreted drug amount at specified sampling intervals (calculated using the concentration data)
Measured: Day 1 (0 to 24 Hours After Dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2010
- Study completionNov 2010
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.
- More trials run by BiogenThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acorda Therapeutics
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215084
- Sponsor's protocol ID
- 218HV101
- Status last verified
- Jul 2014
- First submitted
- 16 Sep 2010
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01215084
- Acronym / sponsor ID
- 218HV101
- Conditions
- Healthy
- Keywords
- Human Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- Acorda Therapeutics
- Study start
- Oct 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 6 Oct 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.
The primary objective of the study is to determine the Pharmacokinetic (PK) and safety profiles of fampridine-PR 10 mg in Chinese and Japanese adult healthy volunteers. The secondary objective of this study is to compare the PK and safety profiles of fampridine-PR 10 mg among the Chinese, Japanese, and Caucasian adult healthy volunteers.
Detailed description
The Caucasian group is included to allow comparison of pharmacokinetic and safety data from different race groups to be performed with data obtained from the same study under the same controlled conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chinese Subpopulation: Fampridine-PR 10 mg | Experimental | Drug: BIIB041 (Fampridine-PR)Chinese ethnic participants were administered a single dose of Fampridine-PR 10 mgs |
| Japanese Subpopulation: Fampridine-PR 10mg | Experimental | Drug: BIIB041 (Fampridine-PR)Japanese ethnic participants were administered a single dose of Fampridine-PR 10 mgs |
| Caucasian Subpopulation: Fampridine-PR 10mg | Experimental | Drug: BIIB041 (Fampridine-PR)Caucasian ethnic participants were administered a single dose of Fampridine-PR 10 mgs |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Subjects of Chinese or Japanese origin (at least both maternal and paternal grandparents of Chinese or Japanese origin, respectively), or Caucasian subjects. Japanese subjects should be on Japanese diet on a regular basis.
- All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 weeks after their single dose of study treatment.
- Body Mass Index (BMI) within the range 18.5 to 30 kg/m2 (inclusive).
- Normal urinalysis results as determined by the Investigator for the following parameters: protein, glucose, specific gravity, ketones, urobilinogen, bilirubin, pH, and blood.
Key exclusion criteria (20 listed)
- Known history of human immunodeficiency virus (HIV) infection or positive test result for HIV antibodies.
- Known history of hepatitis B or hepatitis C infection, hepatitis B carrier (positive test result for Hepatitis B Surface Antigen [HBsAg]), or hepatitis C infection (positive test result for Hepatitis C virus antibody [HCV Ab]).
- Psychiatric or neurological disorders.
- History of epilepsy or other convulsive disorders.
- Any cardiovascular, renal, gastrointestinal, respiratory, metabolic disorder, or other major disease, as determined by the Investigator.
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 |
|---|---|---|
| BIIB041 (Fampridine-PR)Also: AMPYRA®, Dalfampridine, FAMPYRA®A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants | Drug | Caucasian Subpopulation: Fampridine-PR 10mg, Chinese Subpopulation: Fampridine-PR 10 mg, Japanese Subpopulation: Fampridine-PR 10mg |
Primary outcome
Percentage of participants with treatment-emergent adverse events in each ethnic group
Time frame: Day 1 to Day 7
Observed maximum (peak) plasma 4-aminopyridine (4-AP) concentration (Cmax)
Time frame: Day 1 (0 to 24 Hours After Dosing)
Time to reach Cmax following study treatment administration (Tmax)
Time frame: Day 1 (0 to 24 Hours After Dosing)
Area under the time-concentration curve from time zero to infinity (AUC0-∞)
Time frame: Day 1 (0 to 24 Hours After Dosing)
Apparent elimination half-life (T1/2)
Time frame: Day 1 (0 to 24 Hours After Dosing)
Renal clearance of the drug from plasma
Time frame: Day 1 (0 to 24 Hours After Dosing)
Renal clearance as a fraction of total clearance
Time frame: Day 1 (0 to 24 Hours After Dosing)
Cumulative excreted drug amount at specified sampling intervals (calculated using the concentration data)
Time frame: Day 1 (0 to 24 Hours After Dosing)
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 9 Jul 2014.
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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.
Medical Director study director
Biogen
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIIB041 (Fampridine-PR) in people with Healthy, run by Biogen at 2 sites in 2 countries.
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 20 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 9 Jul 2014. 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 Australia, Hong Kong. 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?
Percentage of participants with treatment-emergent adverse events in each ethnic group (time frame: Day 1 to Day 7). The study lists 8 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 9 Jul 2014.