- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01215084
A Pharmacokinetics (PK) and Safety Study of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
July 7, 2014 updated by: Biogen
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- 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.
Key Exclusion Criteria:
- 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).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chinese Subpopulation: Fampridine-PR 10 mg
Chinese ethnic participants were administered a single dose of Fampridine-PR 10 mgs
|
A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants
Other Names:
|
Experimental: Japanese Subpopulation: Fampridine-PR 10mg
Japanese ethnic participants were administered a single dose of Fampridine-PR 10 mgs
|
A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants
Other Names:
|
Experimental: Caucasian Subpopulation: Fampridine-PR 10mg
Caucasian ethnic participants were administered a single dose of Fampridine-PR 10 mgs
|
A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of participants with treatment-emergent adverse events in each ethnic group
Time Frame: Day 1 to Day 7
|
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)
|
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)
|
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)
|
Day 1 (0 to 24 Hours After Dosing)
|
Apparent elimination half-life (T1/2)
Time Frame: Day 1 (0 to 24 Hours After Dosing)
|
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)
|
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)
|
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)
|
Day 1 (0 to 24 Hours After Dosing)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
September 16, 2010
First Submitted That Met QC Criteria
October 4, 2010
First Posted (Estimate)
October 6, 2010
Study Record Updates
Last Update Posted (Estimate)
July 9, 2014
Last Update Submitted That Met QC Criteria
July 7, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 218HV101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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