Single-Dose Study of a New Formulation of BIIB061

• Register: ClinicalTrials.gov
• Last refreshed on: 14 September 2015
• Main ID: NCT02521545
• Date of registration: 16/07/2015
• Prospective Registration: No
• Primary sponsor: Biogen
• Public title: Single-Dose Study of a New Formulation of BIIB061
• Scientific title: A Single-Dose Study in Healthy Volunteers to Assess the Pharmacokinetic Profile of a New Formulation of BIIB061
• Date of first enrolment: July 2015
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02521545
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: BIIB061

Primary Outcome(s)

PK parameter - area under the concentration-time curve from time 0 to infinity (AUCinf) [Time Frame: Day 1-4, 6, 10, 14, 21]

PK parameter - maximum observed concentration (Cmax) [Time Frame: Day 1-4, 6, 10, 14, 21]

PK parameter - AUC from time 0 to time of the last measurable concentration (AUClast) [Time Frame: Day 1-4, 6, 10, 14, 21]

Secondary Outcome(s)

Assessment of changes from baseline in Clinical laboratory parameters [Time Frame: Up to 21 days]

Incidence of adverse events (AEs) and serious adverse events (SAEs) [Time Frame: Up to 21 days]

Assessment of physical examinations [Time Frame: Up to 21 days]

PK parameter - Time to reach maximum observed concentration (Tmax) [Time Frame: Day 1-4, 6, 10, 14, 21]

Assessment of clinically relevant abnormalities in Vital signs [Time Frame: Up to 21 days]

PK parameter - half-life (t1/2) [Time Frame: Day 1-4, 6, 10, 14, 21]

Secondary ID(s)

231HV103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors