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

NCT01215084 | Completed Phase 1

• 1 other identifier: 218HV101
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 2

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.

Conditions

Healthy

Keywords

Human Volunteers

Outcome Measures

Primary Outcomes (8)

• Percentage of participants with treatment-emergent adverse events in each ethnic group

  Day 1 to Day 7

• Observed maximum (peak) plasma 4-aminopyridine (4-AP) concentration (Cmax)

  Day 1 (0 to 24 Hours After Dosing)

• Time to reach Cmax following study treatment administration (Tmax)

  Day 1 (0 to 24 Hours After Dosing)

• Area under the time-concentration curve from time zero to infinity (AUC0-∞)

  Day 1 (0 to 24 Hours After Dosing)

• Apparent elimination half-life (T1/2)

  Day 1 (0 to 24 Hours After Dosing)

• Renal clearance of the drug from plasma

  Day 1 (0 to 24 Hours After Dosing)

• Renal clearance as a fraction of total clearance

  Day 1 (0 to 24 Hours After Dosing)

• Cumulative excreted drug amount at specified sampling intervals (calculated using the concentration data)

  Day 1 (0 to 24 Hours After Dosing)

Study Arms (3)

Chinese Subpopulation: Fampridine-PR 10 mg

EXPERIMENTAL

Chinese ethnic participants were administered a single dose of Fampridine-PR 10 mgs

Drug: BIIB041 (Fampridine-PR)

Japanese Subpopulation: Fampridine-PR 10mg

EXPERIMENTAL

Japanese ethnic participants were administered a single dose of Fampridine-PR 10 mgs

Drug: BIIB041 (Fampridine-PR)

Caucasian Subpopulation: Fampridine-PR 10mg

EXPERIMENTAL

Caucasian ethnic participants were administered a single dose of Fampridine-PR 10 mgs

Drug: BIIB041 (Fampridine-PR)

Interventions

BIIB041 (Fampridine-PR) DRUG

A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants

Also known as: AMPYRA®, Dalfampridine, FAMPYRA®

Caucasian Subpopulation: Fampridine-PR 10mg; Chinese Subpopulation: Fampridine-PR 10 mg; Japanese Subpopulation: Fampridine-PR 10mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Biogen: lead
• Acorda Therapeutics: collaborator

Study Sites (2)

Research Site

Melbourne, Australia

Location

Research Site

Shatin, Hong Kong

Location

MeSH Terms

Interventions

4-Aminopyridine

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: October 6, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

AU (1); HK (1)