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

• ClinicalTrials.gov Identifier: NCT01215084
• Recruitment Status: Completed
• First Posted: October 6, 2010
• Last Update Posted: July 9, 2014
• Sponsor: Biogen
• Collaborator: Acorda Therapeutics
• Information provided by (Responsible Party): Biogen

Study Description

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.

Study Design

• 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

Arms and Interventions

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®

Outcome Measures

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) ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Australia

Research Site

Melbourne, Australia

Hong Kong

Research Site

Shatin, Hong Kong

Sponsors and Collaborators

Biogen

Acorda Therapeutics

Investigators

• Study Director: Medical Director; Biogen

More Information

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT01215084
• Other Study ID Numbers: 218HV101
• First Posted: October 6, 2010
• Last Update Posted: July 9, 2014
• Last Verified: July 2014

Keywords provided by Biogen:

Human Volunteers

Additional relevant MeSH terms:

4-Aminopyridine; Potassium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action