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A Pharmacokinetics (PK) and Safety Study of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01215084
Recruitment Status : Completed
First Posted : October 6, 2010
Last Update Posted : July 9, 2014
Sponsor:
Collaborator:
Acorda Therapeutics
Information provided by (Responsible Party):
Biogen

Brief 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 healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: BIIB041 (Fampridine-PR) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chinese Subpopulation: Fampridine-PR 10 mg
Chinese ethnic participants were administered a single dose of Fampridine-PR 10 mgs
Drug: BIIB041 (Fampridine-PR)
A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants
Other Names:
  • AMPYRA®
  • Dalfampridine
  • FAMPYRA®

Experimental: Japanese Subpopulation: Fampridine-PR 10mg
Japanese ethnic participants were administered a single dose of Fampridine-PR 10 mgs
Drug: BIIB041 (Fampridine-PR)
A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants
Other Names:
  • AMPYRA®
  • Dalfampridine
  • FAMPYRA®

Experimental: Caucasian Subpopulation: Fampridine-PR 10mg
Caucasian ethnic participants were administered a single dose of Fampridine-PR 10 mgs
Drug: BIIB041 (Fampridine-PR)
A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants
Other Names:
  • AMPYRA®
  • Dalfampridine
  • FAMPYRA®




Primary Outcome Measures :
  1. Percentage of participants with treatment-emergent adverse events in each ethnic group [ Time Frame: Day 1 to Day 7 ]
  2. Observed maximum (peak) plasma 4-aminopyridine (4-AP) concentration (Cmax) [ Time Frame: Day 1 (0 to 24 Hours After Dosing) ]
  3. Time to reach Cmax following study treatment administration (Tmax) [ Time Frame: Day 1 (0 to 24 Hours After Dosing) ]
  4. Area under the time-concentration curve from time zero to infinity (AUC0-∞) [ Time Frame: Day 1 (0 to 24 Hours After Dosing) ]
  5. Apparent elimination half-life (T1/2) [ Time Frame: Day 1 (0 to 24 Hours After Dosing) ]
  6. Renal clearance of the drug from plasma [ Time Frame: Day 1 (0 to 24 Hours After Dosing) ]
  7. Renal clearance as a fraction of total clearance [ Time Frame: Day 1 (0 to 24 Hours After Dosing) ]
  8. Cumulative excreted drug amount at specified sampling intervals (calculated using the concentration data) [ Time Frame: Day 1 (0 to 24 Hours After Dosing) ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215084


Locations
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Australia
Research Site
Melbourne, Australia
Hong Kong
Research Site
Shatin, Hong Kong
Sponsors and Collaborators
Biogen
Acorda Therapeutics
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01215084    
Other Study ID Numbers: 218HV101
First Posted: October 6, 2010    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014
Keywords provided by Biogen:
Human Volunteers
Additional relevant MeSH terms:
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4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action