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The primary objective of Part 1 of this study is to evaluate the safety and tolerability of the intravenous (IV) dose of GDC-0973. The primary objectives of Part 2 of this study are to evaluate the absolute bioavailability of GDC-0973 and to evaluate the pharmacokinetic (PK) of GDC-0973 following IV and oral administration. The secondary objective of Part 2 of this study is to evaluate the safety of GDC-0973 administered orally and intravenously.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: GDC-0973 IV Infusion First, Then GDC-0973 Capsules | Experimental | Participants will receive single dose of GDC-0973 2 milligrams (mg) IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. The washout period between each period will be a minimum of 10 days. |
|
| Part 2: GDC-0973 IV Infusion First, Then GDC-0973 Capsules | Experimental | Participants will receive single dose of GDC-0973 2 mg IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. The washout period between each period will be a minimum of 10 days. |
|
| Part 2: GDC-0973 Capsules First, Then GDC-0973 IV Infusion | Experimental | Participants will receive single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in first intervention period followed by single dose of GDC-0973 2 mg IV infusion in second intervention period. The washout period between each period will be a minimum of 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0973 IV Infusion | Drug | IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of IV and Oral GDC-0973 | Part 2: 0 hours (Hrs) (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 | |
| Dose Normalized Cmax [Cmax(dn)] of IV and Oral GDC-0973 | Cmax(dn) is Cmax divided by dose. | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
| Minimum Observed Plasma Trough Concentration (Cmin) of IV and Oral GDC-0973 | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of IV and Oral GDC-0973 | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 | |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of IV and Oral GDC-0973 | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
| Dose Normalized AUC (0-t) [AUC (0-t)dn] of IV and Oral GDC-0973 | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). AUC (0-t)dn is AUC (0-t) divided by dose. | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of IV and Oral GDC-0973 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Rooney, M.D., PhD | Genentech, Inc. | Study Director |
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The study was divided into two parts. In part 1 of the study, safety of GDC-0973 was evaluated and in part 2 pharmacokinetics (PK) of GDC-0973 was evaluated. All PK outcomes apply only to part 2 of the study while safety applies to part 1 and 2 both.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: GDC-0973 IV Infusion First, Then GDC-0973 Capsules | Participants received single dose of GDC-0973 2 milligrams (mg) intravenous (IV) infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period. |
| FG001 | Part 2: GDC-0973 IV Infusion First, Then GDC-0973 Capsules | Participants received single dose of GDC-0973 2 mg IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period. |
| FG002 | Part 2: GDC-0973 Capsules First, Then GDC-0973 IV Infusion | Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in first intervention period followed by single dose of GDC-0973 2 mg IV infusion in second intervention period. There was a washout period of minimum 10 days after each intervention period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Period |
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| First Washout Period |
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| Second Intervention Period |
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| Second Washout Period |
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Safety population included participants who received study drug and had at least 1 post-dose safety assessment for Part 1 and the participants who were randomized, received study drug, and had at least 1 post-dose safety assessment for Part 2.
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Part 1: Participants received single dose of GDC-0973 2 mg IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period. Part 2: Participants received single dose of GDC-0973 2 mg IV infusion and GDC-0973 20 mg oral capsules (four 5-mg capsules) in either of the two intervention periods. There was a washout period of minimum 10 days after each intervention period. |
| 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 |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of IV and Oral GDC-0973 | Full analysis population included participants who were randomized, received study drug, and had at least 1 valid PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Part 2: 0 hours (Hrs) (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
|
Adverse events were recorded from start of study treatment in first period to end of second period (up to 30 days)
Safety population. One participant discontinued study in first period (Part 2) and did not receive GDC-0973 20 mg oral dose in second period. Therefore, only 12 participants were evaluable for adverse events in this treatment arm.
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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 | GDC-0973 2 mg IV | Participants received GDC-0973 2 mg IV infusion in either intervention period in part 1 and part 2 of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| C574276 | cobimetinib |
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| GDC-0973 Oral Capsules | Drug | Oral dose. |
|
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AUC (0 - ∞)= Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). |
| Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
| Dose Normalized AUC (0 - ∞) [AUC (0 - ∞)dn] of IV and Oral GDC-0973 | AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞)dn is AUC(0 - ∞) divided by dose. | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
| Plasma Decay Half-Life (t1/2) of IV and Oral GDC-0973 | t1/2 is the time measured for the plasma concentration of GDC-0973 to decrease by one half. | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
| Systemic Clearance (CL) of IV GDC-0973 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
| Apparent Oral Clearance (CL/F) of Oral GDC-0973 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modelling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
| Volume of Distribution at Steady State (Vss) of IV GDC-0973 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state. | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose of Day 1 |
| Apparent Volume of Distribution (Vz/F) of Oral GDC-0973 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed. | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
| Absolute Oral Bioavailability (F) of GDC-0973 | Absolute oral bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose. F = [AUC (0-∞), oral multiplied by Dose IV] divided by [AUC (0-∞), IV multiplied by Dose oral]. Absolute oral bioavailability is determined for drugs which are administered orally. IV dose is 100% in systemic circulation (dosed directly) and hence no estimation is required. | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
| Mean Absorption Time (MAT) | MAT is mean time required for the drug to reach the central compartment. MAT was estimated from the mean resident time (MRT) from oral and IV administration. MAT was calculated as MRT last of oral dose minus MRT last of IV dose. MAT is analyzed when drug is administered orally (only for non-IV routes of administration). | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
| Amount of Drug Excreted in the Urine (Aeu) of IV and Oral GDC-0973 | The cumulative amount of drug excreted in urine over the entire collection interval of 96 hrs was calculated by adding the Aeu of the intervals 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 hrs where Aeu was calculated by multiplying the urine volume within the collection interval by the associated drug concentration. | Part 2: 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose on Day 1 |
| Renal Clearance (CLR) of IV and Oral GDC-0973 | CLR was calculated as Aeu divided by AUC (0 - ∞), where Aeu was amount of drug excreted in urine from time 0 to 96 hrs post-dose and AUC(0 - ∞) was area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity hrs post-dose. | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 for plasma; 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose for urine |
| Percent of GDC-0973 Excreted in the Urine (% Excreted) for IV and Oral GDC-0973 | % Excreted is the mean percentage of dose recovery in urine and calculated as: (Aeu divided by dose) multiplied by 100, where Aeu was amount of drug excreted in urine from time 0 to 96 hrs post-dose. | Part 2: 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Dose Normalized Cmax [Cmax(dn)] of IV and Oral GDC-0973 | Cmax(dn) is Cmax divided by dose. | Full analysis population. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL/mg | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
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| Primary | Minimum Observed Plasma Trough Concentration (Cmin) of IV and Oral GDC-0973 | Full analysis population. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
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| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of IV and Oral GDC-0973 | Full analysis population. | Posted | Median | Full Range | hr | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
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| Primary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of IV and Oral GDC-0973 | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). | Full analysis population. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
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| Primary | Dose Normalized AUC (0-t) [AUC (0-t)dn] of IV and Oral GDC-0973 | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). AUC (0-t)dn is AUC (0-t) divided by dose. | Full analysis population. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL/mg | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
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| Primary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of IV and Oral GDC-0973 | AUC (0 - ∞)= Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). | Full analysis population. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
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| Primary | Dose Normalized AUC (0 - ∞) [AUC (0 - ∞)dn] of IV and Oral GDC-0973 | AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞)dn is AUC(0 - ∞) divided by dose. | Full analysis population. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL/mg | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
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| Primary | Plasma Decay Half-Life (t1/2) of IV and Oral GDC-0973 | t1/2 is the time measured for the plasma concentration of GDC-0973 to decrease by one half. | Full analysis population. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
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| Primary | Systemic Clearance (CL) of IV GDC-0973 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | Full analysis population who received IV dose of GDC-0973. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter (L)/hr | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
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| Primary | Apparent Oral Clearance (CL/F) of Oral GDC-0973 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modelling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Full analysis population who received oral dose of GDC-0973. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
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| Primary | Volume of Distribution at Steady State (Vss) of IV GDC-0973 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state. | Full analysis population who received IV dose of GDC-0973. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose of Day 1 |
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| Primary | Apparent Volume of Distribution (Vz/F) of Oral GDC-0973 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed. | Full analysis population who received oral dose of GDC-0973. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
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| Primary | Absolute Oral Bioavailability (F) of GDC-0973 | Absolute oral bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose. F = [AUC (0-∞), oral multiplied by Dose IV] divided by [AUC (0-∞), IV multiplied by Dose oral]. Absolute oral bioavailability is determined for drugs which are administered orally. IV dose is 100% in systemic circulation (dosed directly) and hence no estimation is required. | Full analysis population who received oral dose of GDC-0973. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
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| Primary | Mean Absorption Time (MAT) | MAT is mean time required for the drug to reach the central compartment. MAT was estimated from the mean resident time (MRT) from oral and IV administration. MAT was calculated as MRT last of oral dose minus MRT last of IV dose. MAT is analyzed when drug is administered orally (only for non-IV routes of administration). | Full analysis population who received oral dose of GDC-0973. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 |
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| Primary | Amount of Drug Excreted in the Urine (Aeu) of IV and Oral GDC-0973 | The cumulative amount of drug excreted in urine over the entire collection interval of 96 hrs was calculated by adding the Aeu of the intervals 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 hrs where Aeu was calculated by multiplying the urine volume within the collection interval by the associated drug concentration. | Full analysis population. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg | Part 2: 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose on Day 1 |
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| Primary | Renal Clearance (CLR) of IV and Oral GDC-0973 | CLR was calculated as Aeu divided by AUC (0 - ∞), where Aeu was amount of drug excreted in urine from time 0 to 96 hrs post-dose and AUC(0 - ∞) was area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity hrs post-dose. | Full analysis population. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 for plasma; 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose for urine |
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| Primary | Percent of GDC-0973 Excreted in the Urine (% Excreted) for IV and Oral GDC-0973 | % Excreted is the mean percentage of dose recovery in urine and calculated as: (Aeu divided by dose) multiplied by 100, where Aeu was amount of drug excreted in urine from time 0 to 96 hrs post-dose. | Full analysis population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percent dose excreted | Part 2: 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose |
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| 0 |
| 13 |
| 2 |
| 13 |
| EG001 | GDC-0973 20 mg Oral | Participants received GDC-0973 20 mg oral capsules (four 5-mg capsule) in either intervention period in part 1 and part 2 of the study. | 0 | 12 | 3 | 12 |
| Abdominal distension | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Feeling hot | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Infusion site erythema | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (13.1) | 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.