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This is a two-part study to determine the relative bioavailability of two different prototype capsules of GDC-0134 to that of an existing reference capsule of GDC-0134 under both fed and fasted conditions. The study is open to healthy female participants of non-childbearing potential.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I: GDC-0134 F16 vs F09 Capsule Formulation | Experimental | In Part 1 participants will receive single doses of either GDC-0134 F16 capsules (prototype) or GDC-0134 F09 capsules (reference) after having consumed a standard meal. |
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| Part II: GDC-0134 F15 vs F09 Capsule Formulation | Experimental | In Part 2, participants will receive a single dose of either GDC-0134 F15 capsules (prototype) or GDC-0134 F09 capsules (reference) after an overnight fast. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0134 F09 Formulation | Drug | Participants will receive a single oral dose of GDC-0134 reference capsule F09. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of GDC-0134. | The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose. | |
| Area Under the Curve Extrapolated to Infinity (AUCinf) of GDC-0134 | The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | From baseline through the end of study (approximately 11 weeks) |
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Inclusion Criteria
Exclusion Criteria
Healthy female participants of non-childbearing potential
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Research Unit - Daytona | Daytona Beach | Florida | 32117 | United States | ||
| Covance Research Unit - Dallas |
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Screening period: Day -28 to Day 2
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: GDC-0134 F09 vs GDC-0134 F16 Capsule Formulation | In Part 1 participants received single doses of either GDC-0134 F09 or GDC-0134 F16 capsules (prototype) after having consumed a standard meal. |
| FG001 | Part 1: GDC-0134 F16 vs GDC-0134 F09 Capsule Formulation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 19, 2018 | Aug 24, 2020 |
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| GDC-0134 F15 Formulation | Drug | Participants will receive a single oral dose of GDC-0134 prototype capsule F15. |
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| GDC-0134 F16 Formulation | Drug | Participants will receive a single oral dose of GDC-0134 prototype capsule F16. |
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| Dallas |
| Texas |
| 75247 |
| United States |
In Part 1, participants received a single dose of either GDC-0134 F16 capsules or GDC-0134 F09 capsules after after having consumed a standard meal. |
| FG002 | Part 2: GDC-0134 F09 vs GDC-0134 F15 Capsule Formulation | In Part 2 participants received single doses of either GDC-0134 F09 or GDC-0134 F15 capsules (prototype) in fasting conditions. |
| FG003 | Part 2: GDC-0134 F15 vs GDC-0134 F09 Capsule Formulation | In Part 2 participants received single doses of either GDC-0134 F15 or GDC-0134 F09 capsules (prototype) in fasting conditions. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part I: GDC-0134 F09 vs GDC-0134 F16 Capsule Formulation | In Part 1 participants received single doses of either GDC-0134 F09 capsules (prototype) or GDC-0134 F16 capsules (reference) after having consumed a standard meal. |
| BG001 | Part 1: GDC-0134 F16 vs GDC-0134 F09 Capsule Formulation | In Part 1, participants received a single dose of either GDC-0134 F16 capsules or GDC-0134 F09 capsules after after having consumed a standard meal. |
| BG002 | Part 2: GDC-0134 F09 vs GDC-0134 F15 Capsule Formulation | In Part 2 participants received single doses of either GDC-0134 F09 or GDC-0134 F15 capsules (prototype) in fasting conditions. |
| BG003 | Part 2: GDC-0134 F15 vs GDC-0134 F09 Capsule Formulation | In Part 2 participants received single doses of either GDC-0134 F15 or GDC-0134 F09 capsules (prototype) in fasting conditions. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kg |
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| Height | Mean | Standard Deviation | cm |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Maximum Observed Concentration (Cmax) of GDC-0134. | Posted | Geometric Mean | Geometric Coefficient of Variation | uM | The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose. |
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| Secondary | Percentage of Participants With Adverse Events (AEs) | Posted | Number | Percentage of Participants | From baseline through the end of study (approximately 11 weeks) |
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| Primary | Area Under the Curve Extrapolated to Infinity (AUCinf) of GDC-0134 | Posted | Geometric Mean | Geometric Coefficient of Variation | uM.h | The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose. |
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From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part I: GDC-0134 F09 vs GDC-0134 F16 Capsule Formulation | In Part 1 participants received single doses of either GDC-0134 F09 capsules (prototype) or GDC-0134 F16 capsules (reference) after having consumed a standard meal. | 0 | 19 | 0 | 19 | 10 | 19 |
| EG001 | Part II: GDC-0134 F15 vs F09 Capsule Formulation | In Part 2, participants received a single dose of either GDC-0134 F15 capsules (prototype) or GDC-0134 F09 capsules (reference) after an overnight fast. | 0 | 19 | 0 | 19 | 10 | 19 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedRA 21.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedRA 21.1 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedRA 21.1 | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | MedRA 21.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedRA 21.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedRA 21.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedRA 21.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedRA 21.1 | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedRA 21.1 | Non-systematic Assessment |
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| Haematocrit decreased | Investigations | MedRA 21.1 | Non-systematic Assessment |
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| Mean cell volume decreased | Investigations | MedRA 21.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedRA 21.1 | Non-systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedRA 21.1 | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedRA 21.1 | Non-systematic Assessment |
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| Vessel puncture site swelling | General disorders | MedRA 21.1 | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedRA 21.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedRA 21.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedRA 21.1 | Non-systematic Assessment |
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| Eye pain | Eye disorders | MedRA 21.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedRA 21.1 | Non-systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedRA 21.1 | Non-systematic Assessment |
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| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedRA 21.1 | Non-systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Genentech, Inc | 1-800-821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2019 | Aug 24, 2020 | SAP_001.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Geometric LS Mean Ratio |
| 0.9864 |
| 2-Sided |
| 90 |
| 0.8531 |
| 1.1405 |
| Equivalence |
Equivalence margin 80% - 125% |
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| Units | Counts |
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| Participants |
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