Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a monomethyl fumerate (MMF) molecule.
This study record was previously posted/updated by Alkermes, Inc. As of 29 Oct 2019, the sponsorship of the trial was transferred to Biogen along with responsibility for subsequent updates to the record.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Drug | Experimental | Oral capsules |
|
| Active Control | Active Comparator | Oral capsules |
|
| Placebo | Placebo Comparator | Oral capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Drug | Drug |
|
| |
| Active Control |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability will be measured by incidence of adverse events | up to 27 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Concentrations will be measured predose and at 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose | up to 27 days |
| Time to attain Cmax (Tmax) |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Austin | Texas | United States |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
| D005650 | Fumarates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Placebo | Drug |
|
|
| Up to 27 days |
| Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast) | Up to 27 days |
| Area under the concentration-time curve from time 0 to infinity (AUCinf) | Up to 27 days |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003998 |
| Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |