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 is a Phase I, single-center, three-arm, randomized, double-blind, active- and placebo-controlled study to investigate the effect of GDC-0449 on the QT/QTc interval in healthy female subjects of non-childbearing potential.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Active Comparator |
| |
| C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0449 | Drug | Oral repeating dose |
| |
| moxifloxacin |
| Measure | Description | Time Frame |
|---|---|---|
| The QTcF (QT interval corrected by Fridericia's correction method) | Throughout study or until early discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ECG from baseline | Throughout study or until early discontinuation | |
| Pharmacokinetic parameters of GDC-0449 | Throughout study or until early discontinuation | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean Ayache, M.D. | Hoffmann-La Roche | Study Director |
Not provided
| ID | Term |
|---|---|
| C538724 | HhAntag691 |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Oral single dose |
|
| placebo | Drug | Oral repeating dose |
|
| Incidence, nature and severity of adverse events |
| Throughout study or until early discontinuation |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |