Approval Probability
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BIIB061 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| BIIB061 | EXPERIMENTAL | Single oral dose of 30 mg BIIB061 of the new formulation |
| Placebo | PLACEBO_COMPARATOR | Participants receive matched placebo |
| BIIB061 3 mg | EXPERIMENTAL | Fasted participants will receive a single oral dose of BIIB061 3 mg. |
| BIIB061 10 mg | EXPERIMENTAL | Fasted participants will receive a single oral dose of BIIB061 10 mg followed by a tracer amount of 14C-BIIB061 (at ≤ 500 nCi/participant; approximately 4 μg of BIIB061), administered by manual slow intravenous push injection at 4 hours postdose. |
| BIIB061 30 mg | EXPERIMENTAL | Fasted participants will receive a single oral dose of BIIB061 30 mg. Following a washout period, participants will receive the same dose of BIIB061 after a high-fat, high-calorie meal (fed state). |
| BIIB061 60 mg | EXPERIMENTAL | Fasted participants will receive a single oral dose of BIIB061 60 mg. |
| BIIB061 100 mg | EXPERIMENTAL | Fasted participants will receive a single oral dose of BIIB061 100 mg. |
| Name | Type | Description |
|---|---|---|
| BIIB061 | DRUG | Capsule |
| Placebo | OTHER | Matched placebo |
| 14C-BIIB061 | DRUG | Radiolabeled containing 14C-BIIB061 ≤ 500 nCi. |
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 dur...
BIIB061 is an investigational small molecule being studied for use in multiple sclerosis and in healthy volunteers. It is in Phase 1 clinical development and is not yet approved by the FDA. Its exact mechanism of action has not been disclosed.
BIIB061 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The drug is currently in Phase 1 clinical trials.
BIIB061 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. All completed trials for BIIB061 are Phase 1 studies.
BIIB061 has completed three Phase 1 clinical trials: NCT02071121, a single ascending dose study in healthy volunteers; NCT02228707, a safety and pharmacokinetics study in healthy volunteers; and NCT02521545, a single-dose study of a new formulation in multiple sclerosis patients.
No alternative names for BIIB061 have been disclosed. It is referred to solely as BIIB061 in clinical trial records and by its developer, Biogen Inc.