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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000560-33 | EudraCT Number |
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This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: GDC-3280 | Experimental | Participants in multiple cohorts and treatment periods will receive single doses of GDC-3280 under fed/fasting conditions. |
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| Part A: Placebo | Placebo Comparator | Participants in multiple cohorts and treatment periods will receive single doses of placebo under fed/fasting conditions. |
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| Part B: GCD-3280 | Experimental | Participants in different cohorts will receive GDC-3280 in multiple ascending doses under fed/fasting conditions.\n |
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| Part B: Placebo | Placebo Comparator | Participants in different cohorts will receive placebo in multiple ascending doses under fed/fasting conditions.\n |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-3280 | Drug | GDC-3280 at various doses, depending on the cohort and treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing an adverse event | Up to approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) for GDC-3280 | Up to 4 days | |
| Time to Cmax (Tmax) for GDC-3280 | Up to 4 days | |
| Total serum clearance for GDC-3280 |
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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 |
|---|---|---|---|---|---|---|
| Leeds | LS2 9LH | United Kingdom |
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| Placebo | Drug | Placebo at various doses, depending on the cohort and treatment period |
|
| Up to 4 days |
| Volume of distribution for GDC-3280 | Up to 4 days |
| Elimination half-life for GDC-3280 | Up to 4 days |
| Serum GDC-3280 concentration-time data by dosing group | Up to 4 days |