Pharmacokinetics Profile Study of BG00012 Standard Formulation and BG00012 Active Pharmaceutical Ingredient

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01069913
First received: February 12, 2010
Last updated: February 16, 2010
Last verified: February 2010

February 12, 2010
February 16, 2010
October 2009
October 2009   (final data collection date for primary outcome measure)
PK profiles of the current BG00012 standard formulation and the BG00012 API formulation in healthy volunteers. Primary PK parameter will be the area under the plasma concentration curve [ Time Frame: 4 days post dosing period 2 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01069913 on ClinicalTrials.gov Archive Site
To assess the safety and tolerability of the current oral BG00012 standard formulation and the encapsulated oral BG00012 API [ Time Frame: 4 days after dosing period 2 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetics Profile Study of BG00012 Standard Formulation and BG00012 Active Pharmaceutical Ingredient
A Pharmacokinetics Profile Determination of BG00012 Standard Formulation and the BG00012 Active Pharmaceutical Ingredient (API) After a Single Oral Dose Administered to Healthy Male Volunteers

The purpose of this study is to measure two different formulations of BG00012 to determine how much of each formulation of BG00012 reaches the blood stream and how long it takes the body to get rid of it, when given as a single dose.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
Drug: BG00012

Sequence 1: Oral 240 mg BG00012 Standard Formulation & Following 7 day washout period, 240 mg BG00012 API.

Sequence 2: 240 mg BG00012 API & Following 7 day washout period, 240 mg BG00012 Standard Formulation.

  • Active Comparator: BG00012
    BG00012 Standard Formulation
    Intervention: Drug: BG00012
  • Active Comparator: BG00012 API
    BG00012 API
    Intervention: Drug: BG00012
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
January 2010
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Males 18 to 55 years old, inclusive, at the time of informed consent.
  2. Must weigh between 50 kg and 110 kg, inclusive.
  3. Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive.
  4. All subjects must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
  5. Must be a non-smoker, and no use of chewing tobacco, for at least 6 months prior to Day -1.
  6. Must have a screening physical examination and ECG without any clinically significant abnormality (as determined by the Investigator).

Exclusion Criteria:

  1. History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
  2. History of severe allergic or anaphylactic reaction.
  3. History of any clinically significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major diseases, as determined by the Investigator.
  4. Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator.
  5. Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01069913
109HV105
No
Biogen Idec, Medical Director
Biogen Idec
Not Provided
Study Director: Biogen Idec Medical Director Biogen Idec, Cambridge, MA USA
Biogen Idec
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP