Clinical trial NCT02521545: Single-Dose Study of a New Formulation of BIIB061
Official title: A Single-Dose Study in Healthy Volunteers to Assess the Pharmacokinetic Profile of a New Formulation of BIIB061
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Oral Remyelination
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-08-13
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: PK parameter - area under the concentration-time curve from time 0 to infinity (AUCinf)
timeFrame: Day 1-4, 6, 10, 14, 21
measure: PK parameter - AUC from time 0 to time of the last measurable concentration (AUClast)
timeFrame: Day 1-4, 6, 10, 14, 21
measure: PK parameter - maximum observed concentration (Cmax)
timeFrame: Day 1-4, 6, 10, 14, 21
Secondary outcomes:
measure: PK parameter - Time to reach maximum observed concentration (Tmax)
timeFrame: Day 1-4, 6, 10, 14, 21
measure: PK parameter - half-life (t1/2)
timeFrame: Day 1-4, 6, 10, 14, 21
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to 21 days
measure: Assessment of changes from baseline in Clinical laboratory parameters
timeFrame: Up to 21 days
measure: Assessment of clinically relevant abnormalities in Vital signs
timeFrame: Up to 21 days
measure: Assessment of physical examinations
timeFrame: Up to 21 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: