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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01035515 | BIIB014 Cardiovascular Monitoring Study | PHASE1 | COMPLETED | 24 | — | — | Dec 1, 2009 | Apr 1, 2010 | Jun 22, 2010 | 1 | United States |
| NCT01017666 | BIIB014 Effects on the Pharmacokinetics (PK) of Rosiglitazone, Warfarin, and Midazolam | PHASE1 | COMPLETED | 28 | — | — | Nov 1, 2009 | Jun 2, 2010 | Aug 23, 2023 | 1 | United Kingdom |
| NCT00531193 | Using PET Scans to Study Brain Receptor Occupancy of BIIB014 in Healthy Male Volunteers | PHASE1 | COMPLETED | 32 | — | — | Sep 1, 2007 | Apr 1, 2008 | Jul 30, 2008 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Arm One | EXPERIMENTAL | Arm 1 of 6 cross-over arms |
| Arm Two | EXPERIMENTAL | Arm 2 of 6 cross-over arms |
| Arm Three | EXPERIMENTAL | Arm 3 of 6 cross-over arms |
| Arm Four | EXPERIMENTAL | Arm 4 of 6 cross-over arms |
| Arm Five | EXPERIMENTAL | Arm 5 of 6 cross-over arms |
| Arm Six | EXPERIMENTAL | Arm 1 of 6 cross-over arms |
| Rosiglitazone 8mg PO | EXPERIMENTAL | Cohort 1 |
| Midazolam 2mg PO, Warfarin 25mg PO | EXPERIMENTAL | Cohort 2 |
| 1 | OTHER | Various protocol-specified doses of BIIB014 will be used (doses to be determined by PET scan results) |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Single dose oral capsule placebo comparator |
| BIIB014 50mg | DRUG | Single dose oral capsule 50mg BIIB014 |
| BIIB014 100mg | DRUG | Single dose oral capsule 100mg BIIB014 |
| BIIB014 | DRUG | BIIB014 100mg PO Cohort 1 - 8d Cohort 2 - 14d |
| [11C]SCH442416 | OTHER | 11C\]SCH442416 is a radiolabelled tracer molecule that specifically binds to adenosine A2A sites and will be used to evaluate receptor occupancy. The target activity will be 370 MBq. \[11C\]SCH442416 will be administered IV as a bolus injection over 30 seconds following the start of each PET scan. |
Inclusion Criteria: * Healthy male or female subjects * Between the ages of 18 and 50, inclusive. * Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive Exclusion Criteria: * Clinically significant abnormalities (as determined by the Investigator) * Other unspecified reason ...