Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03454126 | Evaluating the Safety, Tolerability, and Pharmacokinetics of BIIB095 in Healthy Participants | PHASE1 | COMPLETED | 80 | — | — | Mar 29, 2018 | Apr 30, 2019 | May 16, 2019 | 2 | United Kingdom |
An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the participant at immediate risk of death (a life threatening event), however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: BIIB095 5 mg | EXPERIMENTAL | Following an overnight fast from food of at least 8 hours, participants will receive a single dose of either BIIB095 5 mg or placebo orally, followed by a fast of at least 4 hours post dose. |
| Cohort 2: BIIB095 25 mg | EXPERIMENTAL | Following an overnight fast from food of at least 8 hours, participants will receive a single dose of either BIIB095 25 mg or placebo orally, followed by a fast of at least 4 hours post dose. |
| Cohort 3: BIIB095 100 mg | EXPERIMENTAL | Following an overnight fast from food of at least 8 hours, participants will receive a single dose of either BIIB095 100 mg or placebo orally, followed by a fast of at least 4 hours post dose. |
| Cohort 4 (Fasted): BIIB095 200 mg | EXPERIMENTAL | Following an overnight fast from food of at least 8 hours, participants will receive a single dose of either BIIB095 200 mg or placebo orally, followed by a fast of at least 4 hours post dose. |
| Cohort 4 (Fed): BIIB095 200 mg | EXPERIMENTAL | After a minimum 2 week washout period, followed by an overnight fast of at least 8 hours, participants will consume a high fat breakfast. Participants will then receive a single dose of either BIIB095 200 mg or placebo orally within 30 minutes after starting the breakfast, followed by a fast from food for at least 4 hours post dose. |
| Cohort 5: BIIB095 400 mg | EXPERIMENTAL | Following an overnight fast from food of at least 8 hours, participants will receive a single dose of either BIIB095 400 mg or placebo orally, followed by a fast of at least 4 hours post dose. |
| Cohort 6: BIIB095 600 mg | EXPERIMENTAL | Following an overnight fast from food of at least 8 hours, participants will receive a single dose of either BIIB095 600 mg or placebo orally, followed by a fast of at least 4 hours post dose. |
| Cohort 7: BIIB095 50 mg BID | EXPERIMENTAL | Participants will receive a single dose of either BIIB095 50 mg or placebo orally BID approximately 12 hours apart from Days 1 to 13, and once in the morning on Day 14. Morning doses will be preceded by an overnight fast from food of at least 8 hours and will be followed by a fast of at least 2 hours post dose. Evening doses will be preceded by a fast from food of at least 2 hours and will be followed by a fast of at least 2 hours post dose. |
| Cohort 8: BIIB095 100 mg BID | EXPERIMENTAL | Participants will receive a single dose of either BIIB095 100 mg or placebo orally BID approximately 12 hours apart from Days 1 to 13, and once in the morning on Day 14. Morning doses will be preceded by an overnight fast from food of at least 8 hours and will be followed by a fast of at least 2 hours post dose. Evening doses will be preceded by a fast from food of at least 2 hours and will be followed by a fast of at least 2 hours post dose. |
| Cohort 9: BIIB095 200 mg BID | EXPERIMENTAL | Participants will receive a single dose of either BIIB095 200 mg or placebo orally BID approximately 12 hours apart from Days 1 to 13, and once in the morning on Day 14. Morning doses will be preceded by an overnight fast from food of at least 8 hours and will be followed by a fast of at least 2 hours post dose. Evening doses will be preceded by a fast from food of at least 2 hours and will be followed by a fast of at least 2 hours post dose. |
| Cohort 10: BIIB095 300 mg BID | EXPERIMENTAL | Participants will receive a single dose of either BIIB095 300 mg or placebo orally BID approximately 12 hours apart from Days 1 to 13, and once in the morning on Day 14. Morning doses will be preceded by an overnight fast from food of at least 8 hours and will be followed by a fast of at least 2 hours post dose. Evening doses will be preceded by a fast from food of at least 2 hours and will be followed by a fast of at least 2 hours post dose. |
| Name | Type | Description |
|---|---|---|
| BIIB095 | DRUG | Administered as specified in the treatment arm. |
| Placebo | DRUG | Administered as specified in the treatment arm. |
Key Inclusion Criteria: * Ability of the subject to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. * Must have a body mass index b...