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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01215084




Registration number
NCT01215084
Ethics application status
Date submitted
16/09/2010
Date registered
6/10/2010
Date last updated
9/07/2014

Titles & IDs
Public title
A Pharmacokinetics (PK) and Safety Study of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
218HV101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BIIB041 (Fampridine-PR)

Experimental: Chinese Subpopulation: Fampridine-PR 10 mg - Chinese ethnic participants were administered a single dose of Fampridine-PR 10 mgs

Experimental: Japanese Subpopulation: Fampridine-PR 10mg - Japanese ethnic participants were administered a single dose of Fampridine-PR 10 mgs

Experimental: Caucasian Subpopulation: Fampridine-PR 10mg - Caucasian ethnic participants were administered a single dose of Fampridine-PR 10 mgs


Treatment: Drugs: BIIB041 (Fampridine-PR)
A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2010
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Shatin

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biogen
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Acorda Therapeutics
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01215084
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01215084