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

Biogen1 site in 1 country36 target enrollmentOctober 2010

ConditionsHealthy

InterventionsBIIB041 (Fampridine-PR)

DrugsBIIB041 (Fampridine-PR)

Overview

Phase: Phase 1
Intervention: BIIB041 (Fampridine-PR)
Conditions: Healthy
Sponsor: Biogen
Enrollment: 36
Locations: 1
Primary Endpoint: Percentage of participants with treatment-emergent adverse events in each ethnic group
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

November 2010

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biogen

Responsible Party

Sponsor

Eligibility Criteria

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.

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.