Single-Dose Study of a New Formulation of BIIB061
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 20 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | July 2015 |
| End Date: | August 2015 |
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.
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.
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
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