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OpenTrials
Completed

NCT Number: NCT01069913

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males 18 to 55 years old, inclusive, at the time of informed consent.
  • Must weigh between 50 kg and 110 kg, inclusive.
  • Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive.
  • 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.
  • Must be a non-smoker, and no use of chewing tobacco, for at least 6 months prior to Day -1.
  • Must have a screening physical examination and ECG without any clinically significant abnormality (as determined by the Investigator).

Exclusion criteria

  • History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
  • History of severe allergic or anaphylactic reaction.
  • 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.
  • Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator.
  • Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.

Treatment and study plan

BG00012

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Feb 17, 2010
Registry last updated
Feb 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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