Single-Dose Study of a New Formulation of BIIB061

A Single-Dose Study in Healthy Volunteers to Assess the Pharmacokinetic Profile of a New Formulation of BIIB061

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: BIIB061

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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.

Key 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIIB061; Single oral dose of 30 mg BIIB061 of the new formulation	Drug: BIIB061; Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PK parameter - area under the concentration-time curve from time 0 to infinity (AUCinf)	Day 1-4, 6, 10, 14, 21
PK parameter - AUC from time 0 to time of the last measurable concentration (AUClast)	Day 1-4, 6, 10, 14, 21
PK parameter - maximum observed concentration (Cmax)	Day 1-4, 6, 10, 14, 21

Secondary Outcome Measures

Outcome Measure	Time Frame
PK parameter - Time to reach maximum observed concentration (Tmax)	Day 1-4, 6, 10, 14, 21
PK parameter - half-life (t1/2)	Day 1-4, 6, 10, 14, 21
Incidence of adverse events (AEs) and serious adverse events (SAEs)	Up to 21 days
Assessment of changes from baseline in Clinical laboratory parameters	Up to 21 days
Assessment of clinically relevant abnormalities in Vital signs	Up to 21 days
Assessment of physical examinations	Up to 21 days

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: July 16, 2015
• First Submitted That Met QC Criteria: August 10, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Estimate): September 7, 2015
• Last Update Submitted That Met QC Criteria: September 3, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Oral Remyelination
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: 231HV103