| Primary | Maximum Observed Plasma Concentration (Cmax) of GDC-9545 | The pharmacokinetics (PK) parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin. The PK parameters Cmax, AUC0-t, and AUC0-∞ for GDC-9545 were analyzed to evaluate the relative bioavailability of GDC-9545 as a Phase 3 capsule formulation compared to a Phase 1 tablet formulation under fasted conditions (Treatment B vs. Treatment A) and to assess the food effect on GDC-9545 PK for a Phase 3 capsule formulation (Treatment C vs. Treatment B). The mixed-effect analysis of variance model for three-period crossover design was used for formulation comparison and fasted state and fed state comparison of capsule. The model included sequence, formulation, and period as fixed effects and a random effect for subject within sequence. An unstructured covariance structure was to be used; however, if it failed to converge, an alternative covariance structure may have been applied. | Pharmacokinetics (PK) Population: all participants who received at least one dose of study drug and had at least one evaluable postdose PK sample, with participants grouped according to the treatment received. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanograms per millilitre (ng/mL) | | Pre-dose (0 hour) and post-dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours on Day 1 and post-dose once a day on Days 2 to 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. | | OG001 | GDC-9545 Capsule, Fasted: Treatment B | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment B. Treatment B consisted of one dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. | | OG002 | GDC-9545 Capsule, Fed: Treatment C | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment C. Treatment C consisted of one dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water within 30 minutes of eating a high-fat meal. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000126± 29.6
- OG001129± 27.7
- OG002102± 27.3
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations. | | | | | Geometric Mean Ratio | 1.03 | | | 2-Sided | 90 | 0.945 | 1.12 | | | The geometric mean ratio was calculated as Treatment B versus Treatment A. | | Other | | | |
|
| Primary | Time to Maximum Observed Plasma Concentration (Tmax) of GDC-9545 | The pharmacokinetics (PK) parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin. The parameter tmax was analyzed nonparametrically using the Wilcoxon signed-rank test. The median difference between the test and reference investigational products (GDC-9545 Phase 3 capsule formulation compared to a Phase 1 tablet formulation under fasted conditions [Treatment B vs. Treatment A] and the food effect on GDC-9545 PK for a Phase 3 capsule formulation [Treatment C vs. Treatment B]) and the corresponding 90% confidence interval were calculated. | Pharmacokinetics (PK) Population: all participants who received at least one dose of study drug and had at least one evaluable postdose PK sample, with participants grouped according to the treatment received. | Posted | | Median | Full Range | Hours | | Pre-dose (0 hour) and post-dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours on Day 1 and post-dose once a day on Days 2 to 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. | | OG001 |
|
| Primary | Time of Last Quantifiable Plasma Concentration (Tlast) of GDC-9545 | The pharmacokinetics parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin. | Pharmacokinetics (PK) Population: all participants who received at least one dose of study drug and had at least one evaluable postdose PK sample, with participants grouped according to the treatment received. | Posted | | Median | Full Range | Hours | | Pre-dose (0 hour) and post-dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours on Day 1 and post-dose once a day on Days 2 to 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. | | OG001 | GDC-9545 Capsule, Fasted: Treatment B | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment B. Treatment B consisted of one dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. |
|
| Primary | Time to First Quantifiable Plasma Concentration (Tlag) of GDC-9545 | The pharmacokinetics parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin. | Pharmacokinetics (PK) Population: all participants who received at least one dose of study drug and had at least one evaluable postdose PK sample, with participants grouped according to the treatment received. | Posted | | Median | Full Range | Hours | | Pre-dose (0 hour) and post-dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours on Day 1 and post-dose once a day on Days 2 to 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. | | OG001 | GDC-9545 Capsule, Fasted: Treatment B | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment B. Treatment B consisted of one dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. |
|
| Primary | Area Under the Plasma Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) of GDC-9545 | The pharmacokinetics (PK) parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin. The PK parameters Cmax, AUC0-t, and AUC0-∞ for GDC-9545 were analyzed to evaluate the relative bioavailability of GDC-9545 as a Phase 3 capsule formulation compared to a Phase 1 tablet formulation under fasted conditions (Treatment B vs. Treatment A) and to assess the food effect on GDC-9545 PK for a Phase 3 capsule formulation (Treatment C vs. Treatment B). The mixed-effect analysis of variance model for three-period crossover design was used for formulation comparison and fasted state and fed state comparison of capsule. The model included sequence, formulation, and period as fixed effects and a random effect for subject within sequence. An unstructured covariance structure was to be used; however, if it failed to converge, an alternative covariance structure may have been applied. | Pharmacokinetics (PK) Population: all participants who received at least one dose of study drug and had at least one evaluable postdose PK sample, with participants grouped according to the treatment received. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*ng/mL | | Pre-dose (0 hour) and post-dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours on Day 1 and post-dose once a day on Days 2 to 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. |
|
| Primary | Area Under the Plasma Concentration-Time Curve From Hour 0 Extrapolated to Infinity (AUC0-∞) of GDC-9545 | The pharmacokinetics (PK) parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin. The PK parameters Cmax, AUC0-t, and AUC0-∞ for GDC-9545 were analyzed to evaluate the relative bioavailability of GDC-9545 as a Phase 3 capsule formulation compared to a Phase 1 tablet formulation under fasted conditions (Treatment B vs. Treatment A) and to assess the food effect on GDC-9545 PK for a Phase 3 capsule formulation (Treatment C vs. Treatment B). The mixed-effect analysis of variance model for three-period crossover design was used for formulation comparison and fasted state and fed state comparison of capsule. The model included sequence, formulation, and period as fixed effects and a random effect for subject within sequence. An unstructured covariance structure was to be used; however, if it failed to converge, an alternative covariance structure may have been applied. | Pharmacokinetics (PK) Population: all participants who received at least one dose of study drug and had at least one evaluable postdose PK sample, with participants grouped according to the treatment received. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*ng/mL | | Pre-dose (0 hour) and post-dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours on Day 1 and post-dose once a day on Days 2 to 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. |
|
| Primary | Percentage of Area Under the Plasma Concentration-Time Curve (AUC) That is Due to Extrapolation From Last Measurable Concentration to Infinity (%AUCextrap) of GDC-9545 | The pharmacokinetics parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin. | Pharmacokinetics (PK) Population: all participants who received at least one dose of study drug and had at least one evaluable postdose PK sample, with participants grouped according to the treatment received. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Percentage of AUC | | Pre-dose (0 hour) and post-dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours on Day 1 and post-dose once a day on Days 2 to 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. | | OG001 | GDC-9545 Capsule, Fasted: Treatment B | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment B. Treatment B consisted of one dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. |
|
| Primary | Apparent Terminal Elimination Rate Constant (λz) of GDC-9545 | The pharmacokinetics parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin. The apparent terminal elimination rate constant (λz) is the magnitude of the slope of the linear regression of the log concentration versus time profile during the terminal phase. | Pharmacokinetics (PK) Population: all participants who received at least one dose of study drug and had at least one evaluable postdose PK sample, with participants grouped according to the treatment received. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Elimination rate per hour (/h) | | Pre-dose (0 hour) and post-dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours on Day 1 and post-dose once a day on Days 2 to 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. | | OG001 | GDC-9545 Capsule, Fasted: Treatment B | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment B. Treatment B consisted of one dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. |
|
| Primary | Apparent Terminal Elimination Half-Life (t1/2) of GDC-9545 | The pharmacokinetics parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin. | Pharmacokinetics (PK) Population: all participants who received at least one dose of study drug and had at least one evaluable postdose PK sample, with participants grouped according to the treatment received. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Pre-dose (0 hour) and post-dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours on Day 1 and post-dose once a day on Days 2 to 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. | | OG001 | GDC-9545 Capsule, Fasted: Treatment B | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment B. Treatment B consisted of one dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. |
|
| Primary | Apparent Total Clearance (CL/F) of GDC-9545 | The pharmacokinetics parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin. | Pharmacokinetics (PK) Population: all participants who received at least one dose of study drug and had at least one evaluable postdose PK sample, with participants grouped according to the treatment received. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Litres per hour (L/h) | | Pre-dose (0 hour) and post-dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours on Day 1 and post-dose once a day on Days 2 to 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. | | OG001 | GDC-9545 Capsule, Fasted: Treatment B | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment B. Treatment B consisted of one dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. |
|
| Primary | Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of GDC-9545 | The pharmacokinetics parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin. | Pharmacokinetics (PK) Population: all participants who received at least one dose of study drug and had at least one evaluable postdose PK sample, with participants grouped according to the treatment received. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Litres (L) | | Pre-dose (0 hour) and post-dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours on Day 1 and post-dose once a day on Days 2 to 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. | | OG001 | GDC-9545 Capsule, Fasted: Treatment B | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment B. Treatment B consisted of one dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. |
|
| Secondary | Number of Participants Who Experienced at Least One Adverse Event by Severity, According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | The investigator sought information on adverse events (AEs) at each contact with a participant. All AEs, whether reported by the participant or noted by study personnel, were recorded. All AEs were assigned a severity grade (from 1 to 5) using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0). Severity refers to the intensity of an AE. The following is the severity grading scale used for AEs that are not specifically listed in the NCI-CTCAE: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life-threatening; and Grade 5 is death related to an AE. | Safety Population: all participants who received at least one dose of study drug, with participants grouped according to the treatment received. | Posted | | Count of Participants | | Participants | | From first dose of study drug until 14 days after the last dose of study drug (up to 41 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. | |
|
| Secondary | Number of Participants With Clinically Significant Abnormalities in Clinical Chemistry, Hematology, and Urinalysis Laboratory Tests | Participants provided blood and urine samples at the specified timepoints for laboratory analysis of clinical chemistry, hematology, and urinalysis parameters (please refer to Appendix A of the protocol for a complete list of parameters). Any of the laboratory test results that were outside of the reference range were considered abnormalities. Not every laboratory abnormality qualified as an adverse event (AE). A laboratory test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment. All AEs were assigned a severity grade (from 1 to 5) using the NCI-CTCAE v5.0; for AEs not specifically listed in the NCI-CTCAE: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life-threatening; and Grade 5 is death related to an AE. | Safety Population: all participants who received at least one dose of study drug, with participants grouped according to the treatment received. | Posted | | Count of Participants | | Participants | | Baseline, Days 2 and 8 of Period 1-3, and 12-14 days after last dose (up to 34 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. |
|
| Secondary | Change From Baseline in Systolic Blood Pressure Over Time | Vital signs (including oral temperature, respiratory rate, and supine blood pressure and pulse rate) were obtained at the specified timepoints. Supine blood pressure was obtained after the participant had been supine for at least 5 minutes. When vital signs were scheduled at the same time as blood draws, the blood draws were obtained at the scheduled timepoint, and the vital signs were obtained as close to the scheduled blood draw as possible, but prior to the blood draw. The baseline value was defined as the last value recorded prior to the first dose in each treatment period. The normal reference range for supine systolic blood pressure was 90-140 millimetres of mercury (mmHg). | Safety Population: all participants who received at least one dose of study drug, with participants grouped according to the treatment received. | Posted | | Mean | Standard Deviation | millimetres of mercury (mmHg) | | Baseline and post-dose on Days 1 to 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. | | OG001 | GDC-9545 Capsule, Fasted: Treatment B |
|
| Secondary | Change From Baseline in Diastolic Blood Pressure Over Time | Vital signs (including oral temperature, respiratory rate, and supine blood pressure and pulse rate) were obtained at the specified timepoints. Supine blood pressure was obtained after the participant had been supine for at least 5 minutes. When vital signs were scheduled at the same time as blood draws, the blood draws were obtained at the scheduled timepoint, and the vital signs were obtained as close to the scheduled blood draw as possible, but prior to the blood draw. The baseline value was defined as the last value recorded prior to the first dose in each treatment period. The normal reference range for supine diastolic blood pressure was 50-90 mmHg. | Safety Population: all participants who received at least one dose of study drug, with participants grouped according to the treatment received. | Posted | | Mean | Standard Deviation | millimetres of mercury (mmHg) | | Baseline and Days 1 to 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. | | OG001 | GDC-9545 Capsule, Fasted: Treatment B |
|
| Secondary | Change From Baseline in Pulse Rate Over Time | Vital signs (including oral temperature, respiratory rate, and supine blood pressure and pulse rate) were obtained at the specified timepoints. Supine pulse rate was obtained after the participant had been supine for at least 5 minutes. When vital signs were scheduled at the same time as blood draws, the blood draws were obtained at the scheduled timepoint, and the vital signs were obtained as close to the scheduled blood draw as possible, but prior to the blood draw. The baseline value was defined as the last value recorded prior to the first dose in each treatment period. The normal reference range for supine pulse rate was 40-100 beats per minute. | Safety Population: all participants who received at least one dose of study drug, with participants grouped according to the treatment received. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline and Days 1 to 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. | | OG001 | GDC-9545 Capsule, Fasted: Treatment B | |
|
| Secondary | Change From Baseline in Respiratory Rate Over Time | Vital signs (including oral temperature, respiratory rate, and supine blood pressure and pulse rate) were obtained at the specified timepoints. When vital signs were scheduled at the same time as blood draws, the blood draws were obtained at the scheduled timepoint, and the vital signs were obtained as close to the scheduled blood draw as possible, but prior to the blood draw. The baseline value was defined as the last value recorded prior to the first dose in each treatment period. The normal reference range for respiratory rate was 10-24 breaths per minute. | Safety Population: all participants who received at least one dose of study drug, with participants grouped according to the treatment received. | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline and Days 1 to 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. | | OG001 | GDC-9545 Capsule, Fasted: Treatment B | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment B. Treatment B consisted of one dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. |
|
| Secondary | Change From Baseline in Oral Body Temperature Over Time | Vital signs (including oral temperature, respiratory rate, and supine blood pressure and pulse rate) were obtained at the specified timepoints. When vital signs were scheduled at the same time as blood draws, the blood draws were obtained at the scheduled timepoint, and the vital signs were obtained as close to the scheduled blood draw as possible, but prior to the blood draw. The baseline value was defined as the last value recorded prior to the first dose in each treatment period. The normal reference range for oral body temperature was 35.5-37.8 degrees Celsius (C). | Safety Population: all participants who received at least one dose of study drug, with participants grouped according to the treatment received. | Posted | | Mean | Standard Deviation | degrees Celsius (C) | | Baseline and Days 1 to 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
|---|
| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. | | OG001 | GDC-9545 Capsule, Fasted: Treatment B | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment B. Treatment B consisted of one dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. |
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| Secondary | Change From Baseline in Duration of PR, RR, QRS, QT, QTcB, and QTcF Intervals Over Time, as Measured by Electrocardiogram | A single 12-lead electrocardiogram (ECG) was obtained at the specified timepoints. To minimize variability in autonomic tone and heart rate, participants rested quietly and in a supine position for at least 5 minutes prior to recording the ECG. Blood draws, other procedures, activity, and environmental distractions (e.g., television, radio, conversation) were to be avoided during the pre-ECG resting period and between ECG recordings to minimize variability due to the effects of activity and stress on cardiac electrophysiology. Whenever possible, ECG tracings for each participant were to be obtained from the same type of machine throughout the study. The baseline value was defined as the last value recorded prior to the first dose in each treatment period. The following are the normal reference ranges for ECG interval durations in milliseconds (msec): PR [120-210 msec]; QRS [upper limit: <120 msec]; QT, QTcB, and QTcF [upper limit: <470 msec]. | Safety Population: all participants who received at least one dose of study drug, with participants grouped according to the treatment received. | Posted | | Mean | Standard Deviation | milliseconds (msec) | | Baseline, and pre-dose and 4 hours post-dose on Day 1, and post-dose on Days 2, and 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
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| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. |
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| Secondary | Change From Baseline in Heart Rate Over Time, as Measured by Electrocardiogram | A single 12-lead electrocardiogram (ECG) was obtained at the specified timepoints. To minimize variability in autonomic tone and heart rate, participants rested quietly and in a supine position for at least 5 minutes prior to recording the ECG. Blood draws, other procedures, activity, and environmental distractions (e.g., television, radio, conversation) were to be avoided during the pre-ECG resting period and between ECG recordings to minimize variability due to the effects of activity and stress on cardiac electrophysiology. Whenever possible, ECG tracings for each participant were to be obtained from the same type of machine throughout the study. The baseline value was defined as the last value recorded prior to the first dose in each treatment period. The normal reference range for heart rate was 50-100 beats per minute. | Safety Population: all participants who received at least one dose of study drug, grouped according to the treatment received. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline, and post-dose on Days 1, 2, and 8 of Periods 1-3 (up to 27 days) | | | | ID | Title | Description |
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| OG000 | GDC-9545 Tablet, Fasted: Treatment A | This analysis population consisted of all participants who were enrolled in the study, regardless of the treatment sequence arm to which they were randomized, and received one dose of GDC-9545 Treatment A. Treatment A consisted of one dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast. |
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