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

NCT01420458 | Completed Phase 1

• 1 other identifier: 109HV107
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

bioequivalence

Outcome Measures

Primary Outcomes (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 Outcomes (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

Interventions

Experimental DRUG

Bioequivalence of two drug formulations

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Minneapolis, Minnesota, United States

Location

Study Design

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

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 19, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 4, 2011

Record last verified: 2011-11

Locations

US (1)