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
What it found
We found no results in the registry or in papers.
This trial finished 11 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Biib061
Unknown
What it measured
Main measures
PK parameter - area under the concentration-time curve from time 0 to infinity (AUCinf)
Day 1-4, 6, 10, 14, 21
How the body handles the medicinePK parameter - AUC from time 0 to time of the last measurable concentration (AUClast)
Day 1-4, 6, 10, 14, 21
How the body handles the medicinePK parameter - maximum observed concentration (Cmax)
Day 1-4, 6, 10, 14, 21
How the body handles the medicine
Other measures (6)
PK parameter - Time to reach maximum observed concentration (Tmax)
Day 1-4, 6, 10, 14, 21
How the body handles the medicinePK parameter - half-life (t1/2)
Day 1-4, 6, 10, 14, 21
MRI lesionsHow the body handles the medicineIncidence of adverse events (AEs) and serious adverse events (SAEs)
Up to 21 days
SafetyAssessment of changes from baseline in Clinical laboratory parameters
Up to 21 days
Assessment of clinically relevant abnormalities in Vital signs
Up to 21 days
SafetyAssessment of physical examinations
Up to 21 days
Who could take part
MS (type not specified) · 20 to 55
Show the full criteria
Inclusion 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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Jul 2015
Main results due
Aug 2015
Finished
Aug 2015