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This study is to assess the pharmacokinetics (PK) of a single dose of pravastatin with and without concomitant GDC-0810 administration in healthy female subjects of non-childbearing potential. During Period 1 (Day -1 to Day 4) PK parameters of pravastatin will be determined in the absence of GDC-0810. During Period 2 (Days 5-28) PK parameters of pravastatin will be determined in the presence of GDC-0810.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Female Healthy Volunteers | Experimental | Healthy volunteer female subjects of non-childbearing potential will be administered pravastatin once on Day 1 during Period 1 (Day -1 to Day 4). During Period 2 (Days 5-28) GDC-0810 will be administered daily on Days 5-8. Pravastatin will be co-administered on Day 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0810 | Drug | During Period 2 subjects will be administered an oral 600 mg dose GDC-0810 daily beginning on Day 5 for 4 consecutive days (from Days 5 to 8, inclusive). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Pravastatin | Days 1-3 (Period 1) and Days 7-10 (Period 2) | |
| Time to Maximum Concentration (Tmax) of Pravastatin | Days 1-3 (Period 1) and Days 7-10 (Period 2) | |
| Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Pravastatin | Days 1-3 (Period 1) and Days 7-10 (Period 2) | |
| Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Pravastatin | Days 1-3 (Period 1) and Days 7-10 (Period 2) | |
| Apparent Volume of Distribution (Vz/F) of Pravastatin | Days 1-3 (Period 1) and Days 7-10 (Period 2) | |
| Apparent Clearance (CL/F) of Pravastatin | Days 1-3 (Period 1) and Days 7-10 (Period 2) | |
| Apparent Terminal Elimination Rate Constant (lambda z) of Pravastatin | Days 1-3 (Period 1) and Days 7-10 (Period 2) | |
| Apparent Terminal Elimination Half-Life (t1/2) of Pravastatin | Days 1-3 (Period 1) and Days 7-10 (Period 2) | |
| Amount of Pravastatin Excreted in Urine (Ae) | Day 1 (Period 1) and Day 7 (Period 2) | |
| Renal Clearance (CLR) of Pravastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of GDC-0810 | Days 7-10 (Period 2) | |
| Time to Maximum Concentration (Tmax) of GDC-0810 | Days 7-10 (Period 2) | |
| Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of GDC-0810 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daytona Beach | Florida | 32117 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000606997 | 3-(4-(2-(2-chloro-4-fluorophenyl)-1-(1H-indazol-5-yl)but-1-en-1-yl)phenyl)acrylic acid |
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Pravastatin | Drug | Subjects will receive a single oral dose of 10 mg pravastatin on Day 1 in Period 1 and Day 7 in Period 2. |
|
|
| Day 1 (Period 1) and Day 7 (Period 2) |
| Percentage of Pravastatin Excreted in Urine (%Excreted) | Day 1 (Period 1) and Day 7 (Period 2) |
| Plasma Concentrations of Pravastatin | Days 1-3 (Period 1) and Days 7-10 (Period 2) |
| Days 7-10 (Period 2) |
| Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of GDC-0810 | Days 7-10 (Period 2) |
| Apparent Volume of Distribution (Vz/F) of GDC-0810 | Days 7-10 (Period 2) |
| Apparent Clearance (CL/F) of GDC-0810 | Days 7-10 (Period 2) |
| Apparent Terminal Elimination Rate Constant (lambda z) of GDC-0810 | Days 7-10 (Period 2) |
| Apparent Terminal Elimination Half-Life (t1/2) of GDC-0810 | Days 7-10 (Period 2) |
| Amount of GDC-0810 Excreted in Urine (Ae) | Day 7 (Period 2) |
| Renal Clearance (CLr) of GDC-0810 | Day 7 (Period 2) |
| Percentage of GDC-0810 Excreted in Urine (%Excreted) | Day 7 (Period 2) |
| Percentage of Participants with Adverse Events (AEs) | From baseline to study completion up to Day 28 |
| Percentage of Participants with Serious Adverse Events (SAEs) | From baseline to study completion up to Day 28 |
| Percentage of Participants with Clinically Significant Changes in Safety Measurements, Including Vital Signs, Electrocardiograms (ECGs), Physical Examination Findings and Clinical Laboratory Results. | From baseline to study completion up to Day 28 |
| Plasma Concentrations of GDC-0810 | Days 7-10 (Period 2) |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |