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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000502-28 | EudraCT Number |
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This single-center, open label, randomized, 3-period cross-over study will compare 3 modified-release formulations of RO4917523 in healthy volunteers. Subjects will be randomized to one of six sequences to receive single oral doses of RO4917523 slow, target and fast release modified release (MR) capsules along with a reference intravenous microdose with the target capsule. A washout period of at least 21 days will occur between treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fast release MR capsule | Experimental |
| |
| Slow release MR capsule | Experimental |
| |
| Target release MR capsule | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO4917523 | Drug | Fast release MR capsule, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration-time curve (AUC) | Pre-dose and up to 144 hours post-dose | |
| Pharmacokinetics: Maximum concentration (Cmax) | Pre-dose and up to 144 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Time to maximum plasma concentration (tmax) | Pre-dose and up to 144 hours post-dose | |
| Pharmacokinetics: Elimination half-life (t1/2) | Pre-dose and up to 144 hours post-dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marlton | New Jersey | 08053 | United States |
| ID | Term |
|---|---|
| C000596770 | 2-chloro-4-(1-(4-fluorophenyl)-2,5-dimethyl-1H-imidazol-4-ylethynyl)pyridine |
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| RO4917523 |
| Drug |
Target release MR capsule, single dose |
|
| RO4917523 | Drug | Slow release MR capsule, single dose |
|
| RO4917523 | Drug | [13C]-labeled tracer dose i.v. |
|
| Pharmacokinetics: Elimination rate constant: (kel) |
| Pre-dose and up to 144 hours post-dose |
| Pharmacokinetics: Absolute bioavailability (F) | Pre-dose and up to 144 hours post-dose |
| Pharmacokinetics: Total body clearance (CL) | Pre-dose and up to 144 hours post-dose |
| Pharmacokinetics: Volume of distribution (Vd) | Pre-dose and up to 144 hours post-dose |
| Safety: Incidence of adverse events | approximately 13 weeks |