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

NCT01069913 | Completed Phase 1

• 1 other identifier: 109HV105
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Keywords

Healthy Volunteer

Outcome Measures

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

  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

  4 days after dosing period 2

Study Arms (2)

BG00012

ACTIVE COMPARATOR

BG00012 Standard Formulation

Drug: BG00012

BG00012 API

ACTIVE COMPARATOR

BG00012 API

Drug: BG00012

Interventions

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.

BG00012; BG00012 API

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

MeSH Terms

Interventions

Dimethyl Fumarate

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Biogen Idec Medical Director

  Biogen Idec, Cambridge, MA USA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 12, 2010
• First Posted: February 17, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: January 1, 2010
• Last Updated: February 17, 2010

Record last verified: 2010-02