Text Size

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
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: BG00012
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BG00012
BG00012 Standard Formulation
 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 API
BG00012 API
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069913

Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Biogen Idec Medical Director Biogen Idec, Cambridge, MA USA
  More Information

No publications provided

Responsible Party: Biogen Idec, Medical Director
ClinicalTrials.gov Identifier: NCT01069913     History of Changes
Other Study ID Numbers: 109HV105
Study First Received: February 12, 2010
Last Updated: February 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Healthy Volunteer

Additional relevant MeSH terms:
Dimethyl fumarate
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 19, 2013