Single-Dose Study of a New Formulation of BIIB061

NCT ID: NCT02521545

Last Updated: 2015-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-08-31

Brief Summary

The primary objective of the study is to assess the pharmacokinetic (PK) profile of BIIB061 in the new oral formulation in the fasted state in healthy male and female volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in the new formulation in this study population.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIIB061

Single oral dose of 30 mg BIIB061 of the new formulation

Group Type: EXPERIMENTAL

BIIB061

Intervention Type: DRUG

Capsule

Interventions

BIIB061

Capsule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Males and postmenopausal (defined as no menses for 12 months and confirmed by follicle-stimulating hormone [FSH] levels determined at screening to be in the postmenopausal range) or surgically sterile females.
• All male subjects must practice effective contraception during the study and be willing and able to continue male contraception for 3 months after the dose of study treatment. All male subjects must also be willing to refrain from sperm donation for at least 3 months after their dose of study treatment.
• Must be in good health and have normal vital signs as determined by the Investigator, based on medical history and screening evaluations.
• Body mass index of 18.0 to 30.0 kg/m2, inclusive.

Exclusion Criteria

• History of or positive test result at screening for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
• Prior exposure to BIIB061.
• History of any clinically significant cardiac, endrocrinologic, hematologic, hepatic, gastric, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, oncologic, or other major disease, as determined by the Investigator.
• Treatment with any prescription medication within 28 days prior to and throughout the duration of the study.
• Use of any over-the-counter products, including herbal or alternative health preparations within the 14 days prior to the study
• Enrollment in any interventional clinical study in which an investigational drug, biologic, device, or approved therapy for investigational use is administered or used within 30 days prior to the study
• Any live or attenuated immunization/vaccination given within 30 days prior to the study or planned to be given during the study.
• Blood donation within 30 days prior to the study
• Surgery within 3 months prior to the study

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Site

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

231HV103

Identifier Type: -

Identifier Source: org_study_id