Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012

• Sponsor: Biogen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01420458
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Duration (Months): 1
• Patients Per Site Per Month: 78.5

Study Details

Study Description

Brief Summary

This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled concurrently.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Experimental	Phase 1

Detailed Description

This is a study of healthy volunteers to demonstrate bioequivalence of two formulations of BG-00012 given in capsule form..

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: A Randomized, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of Two Formulations of BG00012.
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Outcome Measures

Primary Outcome Measures

1. Area under the plasma concentration curve as a measure of PK. [Participants will be followed during the duration of the study, 4 days. Samples taken at -15mins, 30 mins, 60 mins, 90 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 7 hrs, 8 hrs, 10 hrs, 12 hrs]

Secondary Outcome Measures

1. The number of AEs in participants as a measure of safety and tolerability. [Participants will be followed during the time of study - an estimated four days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Must give written and informed consent and any authorizations required by local law.

• Males and females 18 - 55 years old inclusive at time of consent.

• Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive

Exclusion Criteria:

• History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).

• Known history of or positive test result for Human Immunodeficiency Virus (HIV)

• History of severe allergic or anaphylactic reactions.

• History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic,metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric and renal or other major disease, as determined by the Investigator.

• Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator, and any screening values for alanine aminotransferase (ALT) aspartate aminotransferase (AST) total bilirubin, or creatinine above the upper limit of normal, or an out of normal range screening value for white blood cells (WBC).

• Current enrollment in any other drug, biologic, or device study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Minneapolis	Minnesota	United States

Sponsors and Collaborators

• Biogen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01420458
• Other Study ID Numbers: 109HV107
• First Posted: Aug 19, 2011
• Last Update Posted: Nov 4, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by , ,: bioequivalence

Study Results

No Results Posted as of Nov 4, 2011