A Phase 1 interventional study of GDC-9545 Tablet, Fasted: Treatment A and GDC-9545 Capsule, Fasted: Treatment B in Healthy Volunteers, sponsored by Genentech, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 1, Interventional, and Basic science
This study will be an open-label, randomized, three-period, six-sequence crossover study of GDC-9545 administered to healthy females of non-childbearing potential to determine the relative bioavailability of the Phase 3 capsule formulation to the Phase 1 tablet formulation in the fasted state and the effect of food on the Phase 3 capsule formulation.
Genentech, Inc. is the lead sponsor of 517 studies on the registry; 22 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 52 (55%) have results posted.
First submitted after Genentech, Inc. became part of Hoffmann-La Roche.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants randomized to this arm will receive one dose of GDC-9545 at the start of each of three periods according to the treatment sequence A, B, and C (refer to the intervention descriptions). The washout period between doses will be a minimum of 10 days.
Drug: GDC-9545 Tablet, Fasted: Treatment A · Drug: GDC-9545 Capsule, Fasted: Treatment B · Drug: GDC-9545 Capsule, Fed: Treatment C
Participants randomized to this arm will receive one dose of GDC-9545 at the start of each of three periods according to the treatment sequence B, C, and A (refer to the intervention descriptions). The washout period between doses will be a minimum of 10 days.
Drug: GDC-9545 Tablet, Fasted: Treatment A · Drug: GDC-9545 Capsule, Fasted: Treatment B · Drug: GDC-9545 Capsule, Fed: Treatment C
Participants randomized to this arm will receive one dose of GDC-9545 at the start of each of three periods according to the treatment sequence C, A, and B (refer to the intervention descriptions). The washout period between doses will be a minimum of 10 days.
Drug: GDC-9545 Tablet, Fasted: Treatment A · Drug: GDC-9545 Capsule, Fasted: Treatment B · Drug: GDC-9545 Capsule, Fed: Treatment C
Participants randomized to this arm will receive one dose of GDC-9545 at the start of each of three periods according to the treatment sequence A, C, and B (refer to the intervention descriptions). The washout period between doses will be a minimum of 10 days.
Drug: GDC-9545 Tablet, Fasted: Treatment A · Drug: GDC-9545 Capsule, Fasted: Treatment B · Drug: GDC-9545 Capsule, Fed: Treatment C
Participants randomized to this arm will receive one dose of GDC-9545 at the start of each of three periods according to the treatment sequence B, A, and C (refer to the intervention descriptions). The washout period between doses will be a minimum of 10 days.
Drug: GDC-9545 Tablet, Fasted: Treatment A · Drug: GDC-9545 Capsule, Fasted: Treatment B · Drug: GDC-9545 Capsule, Fed: Treatment C
Participants randomized to this arm will receive one dose of GDC-9545 at the start of each of three periods according to the treatment sequence C, B, and A (refer to the intervention descriptions). The washout period between doses will be a minimum of 10 days.
Drug: GDC-9545 Tablet, Fasted: Treatment A · Drug: GDC-9545 Capsule, Fasted: Treatment B · Drug: GDC-9545 Capsule, Fed: Treatment C
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.
Also known as: Giredestrant, RO7197597, RG6171
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.
Also known as: Giredestrant, RO7197597, RG6171
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.
Also known as: Giredestrant, RO7197597, RG6171
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: From first dose of study drug until 14 days after the last dose of study drug (up to 41 days)
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.
Time frame: Baseline, Days 2 and 8 of Period 1-3, and 12-14 days after last dose (up to 34 days)
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).
Time frame: Baseline and post-dose on Days 1 to 8 of Periods 1-3 (up to 27 days)
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.
Time frame: Baseline and Days 1 to 8 of Periods 1-3 (up to 27 days)
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.
Time frame: Baseline and Days 1 to 8 of Periods 1-3 (up to 27 days)
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.
Time frame: Baseline and Days 1 to 8 of Periods 1-3 (up to 27 days)
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).
Time frame: Baseline and Days 1 to 8 of Periods 1-3 (up to 27 days)
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 \[upper limit: \<470 msec\].
Time frame: 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)
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.
Time frame: Baseline, and post-dose on Days 1, 2, and 8 of Periods 1-3 (up to 27 days)
| Milestone | GDC-9545 Treatment Sequence A, B, and C | GDC-9545 Treatment Sequence B, C, and A | GDC-9545 Treatment Sequence C, A, and B | GDC-9545 Treatment Sequence A, C, and B | GDC-9545 Treatment Sequence B, A, and C | GDC-9545 Treatment Sequence C, B, and A |
|---|---|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 | 3 | 3 |
| Completed treatment period 1 (9 days) | 3 | 3 | 3 | 3 | 3 | 3 |
| Completed treatment period 2 (9 days) | 3 | 3 | 3 | 3 | 3 | 3 |
| Completed treatment period 3 (9 days) | 3 | 3 | 3 | 3 | 3 | 3 |
| Completed follow-up visit | 3 | 3 | 3 | 3 | 3 | 3 |
| Completed | 3 | 3 | 3 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| nanograms per millilitre (ng/mL) | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of GDC-9545 | 126 ± 29.6 | 129 ± 27.7 | 102 ± 27.3 |
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.
| Hours | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Time to Maximum Observed Plasma Concentration (Tmax) of GDC-9545 | 2.25 (1.00 to 5.00) | 2.28 (1.50 to 5.00) | 5.00 (3.00 to 6.00) |
The pharmacokinetics parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin.
| Hours | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Time of Last Quantifiable Plasma Concentration (Tlast) of GDC-9545 | 168 (168 to 168) | 168 (168 to 168) | 168 (168 to 168) |
The pharmacokinetics parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin.
| Hours | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Time to First Quantifiable Plasma Concentration (Tlag) of GDC-9545 | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 1.00) |
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.
| Hours*ng/mL | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) of GDC-9545 | 3710 ± 31.8 | 3600 ± 29.8 | 3310 ± 27.6 |
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.
| Hours*ng/mL | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Hour 0 Extrapolated to Infinity (AUC0-∞) of GDC-9545 | 3860 ± 32.6 | 3770 ± 30.8 | 3460 ± 28.1 |
The pharmacokinetics parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin.
| Percentage of AUC | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| 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 | 3.40 ± 58.5 | 3.87 ± 49.8 | 3.78 ± 48.9 |
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.
| Elimination rate per hour (/h) | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Apparent Terminal Elimination Rate Constant (λz) of GDC-9545 | 0.0196 ± 15.7 | 0.0185 ± 15.5 | 0.0188 ± 14.4 |
The pharmacokinetics parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin.
| Hours | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Apparent Terminal Elimination Half-Life (t1/2) of GDC-9545 | 35.4 ± 15.7 | 37.4 ± 15.5 | 36.9 ± 14.4 |
The pharmacokinetics parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin.
| Litres per hour (L/h) | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Apparent Total Clearance (CL/F) of GDC-9545 | 7.76 ± 32.6 | 7.97 ± 30.8 | 8.68 ± 28.1 |
The pharmacokinetics parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin.
| Litres (L) | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of GDC-9545 | 397 ± 29.8 | 430 ± 26.5 | 462 ± 29.8 |
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.
| Participants | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C | Overall: Any GDC-9545 Treatment (A, B, or C) |
|---|---|---|---|---|
| Any Adverse Event (AE), Any Grade | 2 | 2 | 3 | 5 |
| AE by Initial Severity, Grade 1 | 2 | 2 | 2 | 4 |
| AE by Initial Severity, Grade 2 | 0 | 0 | 1 | 1 |
| AE by Initial Severity, Grade 3 | 0 | 0 | 0 | 0 |
| AE by Initial Severity, Grade 4 | 0 | 0 | 0 | 0 |
| AE by Initial Severity, Grade 5 | 0 | 0 | 0 | 0 |
| AE by Most Extreme Severity, Grade 1 | 2 | 2 | 2 | 4 |
| AE by Most Extreme Severity, Grade 2 | 0 | 0 | 1 | 1 |
| AE by Most Extreme Severity, Grade 3 | 0 | 0 | 0 | 0 |
| AE by Most Extreme Severity, Grade 4 | 0 | 0 | 0 | 0 |
| AE by Most Extreme Severity, Grade 5 | 0 | 0 | 0 | 0 |
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.
| Participants | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Number of Participants With Clinically Significant Abnormalities in Clinical Chemistry, Hematology, and Urinalysis Laboratory Tests | 0 | 0 | 1 |
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).
| millimetres of mercury (mmHg) | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Baseline (BL) - Value at Visit | 104.5 ± 12.03 | 103.1 ± 8.73 | 102.6 ± 9.28 |
| Change from BL at Day 1 | -1.7 ± 7.17 | 0.7 ± 10.50 | -3.8 ± 7.33 |
| Change from BL at Day 2 | -5.9 ± 6.93 | -4.0 ± 9.39 | -1.2 ± 7.77 |
| Change from BL at Day 3 | -3.7 ± 7.46 | -1.8 ± 8.71 | -1.1 ± 8.39 |
| Change from BL at Day 4 | -2.8 ± 7.56 | -3.2 ± 7.61 | -2.6 ± 9.65 |
| Change from BL at Day 5 | -4.9 ± 7.03 | -2.6 ± 6.46 | -3.8 ± 6.71 |
| Change from BL at Day 6 | -5.3 ± 8.94 | -1.8 ± 6.39 | -0.6 ± 8.95 |
| Change from BL at Day 7 | -5.2 ± 8.19 | -3.3 ± 7.31 | -2.9 ± 8.12 |
| Change from BL at Day 8 | -3.4 ± 9.23 | -0.4 ± 6.68 | -2.3 ± 6.28 |
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.
| millimetres of mercury (mmHg) | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Baseline (BL) - Value at Visit | 64.2 ± 7.86 | 62.5 ± 8.40 | 62.8 ± 7.67 |
| Change from BL at Day 1 | -2.8 ± 5.31 | -3.1 ± 6.73 | -3.3 ± 6.23 |
| Change from BL at Day 2 | -3.2 ± 6.13 | -2.7 ± 8.73 | -1.6 ± 6.64 |
| Change from BL at Day 3 | -4.2 ± 6.96 | 0.2 ± 7.52 | -1.0 ± 6.87 |
| Change from BL at Day 4 | -2.3 ± 4.67 | -2.3 ± 7.50 | -2.3 ± 6.44 |
| Change from BL at Day 5 | -2.8 ± 7.36 | -0.9 ± 5.31 | -2.3 ± 6.82 |
| Change from BL at Day 6 | -4.3 ± 6.13 | -1.8 ± 6.37 | -0.4 ± 7.22 |
| Change from BL at Day 7 | -3.1 ± 7.07 | -0.9 ± 6.10 | -1.8 ± 6.83 |
| Change from BL at Day 8 | -3.1 ± 6.66 | 0.1 ± 7.45 | -3.3 ± 7.39 |
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.
| Beats per minute | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Baseline (BL) - Value at Visit | 62.2 ± 7.61 | 62.4 ± 8.88 | 65.3 ± 11.00 |
| Change from BL at Day 1 | -2.1 ± 6.27 | -4.1 ± 7.62 | -1.3 ± 9.39 |
| Change from BL at Day 2 | 1.4 ± 10.34 | -3.2 ± 7.65 | -5.4 ± 7.01 |
| Change from BL at Day 3 | -0.6 ± 5.61 | -4.1 ± 6.29 | -4.8 ± 7.73 |
| Change from BL at Day 4 | -1.1 ± 8.08 | -2.2 ± 9.52 | -5.6 ± 7.85 |
| Change from BL at Day 5 | -1.1 ± 6.76 | -2.8 ± 6.67 | -4.7 ± 9.33 |
| Change from BL at Day 6 | -0.2 ± 7.58 | -0.4 ± 8.60 | -4.4 ± 8.56 |
| Change from BL at Day 7 | -0.7 ± 7.10 | -1.4 ± 5.99 | -5.4 ± 8.20 |
| Change from BL at Day 8 | 1.1 ± 9.00 | -0.1 ± 7.19 | -2.6 ± 6.30 |
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.
| Breaths per minute | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Baseline (BL) - Value at Visit | 15.6 ± 1.76 | 15.6 ± 1.89 | 15.6 ± 2.01 |
| Change from BL at Day 1 | 1.6 ± 2.53 | 1.2 ± 1.96 | 2.0 ± 3.14 |
| Change from BL at Day 2 | -0.6 ± 2.90 | -0.7 ± 3.07 | -0.8 ± 2.29 |
| Change from BL at Day 3 | -0.4 ± 2.71 | -0.6 ± 3.55 | -0.6 ± 3.35 |
| Change from BL at Day 4 | 0.1 ± 2.00 | 0.2 ± 2.54 | -0.3 ± 2.68 |
| Change from BL at Day 5 | 0.8 ± 3.60 | 0.1 ± 2.70 | 1.0 ± 2.93 |
| Change from BL at Day 6 | 0.0 ± 2.74 | 0.2 ± 2.37 | -0.6 ± 3.20 |
| Change from BL at Day 7 | -0.4 ± 3.26 | -1.0 ± 3.31 | -0.8 ± 3.15 |
| Change from BL at Day 8 | -0.9 ± 1.97 | -1.1 ± 2.30 | -1.0 ± 2.40 |
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).
| degrees Celsius (C) | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Baseline (BL) - Value at Visit | 36.65 ± 0.142 | 36.64 ± 0.115 | 36.72 ± 0.129 |
| Change from BL at Day 1 | 0.06 ± 0.129 | 0.00 ± 0.124 | 0.04 ± 0.195 |
| Change from BL at Day 2 | 0.12 ± 0.183 | 0.07 ± 0.149 | 0.00 ± 0.150 |
| Change from BL at Day 3 | 0.12 ± 0.140 | 0.11 ± 0.229 | 0.03 ± 0.119 |
| Change from BL at Day 4 | 0.08 ± 0.182 | 0.09 ± 0.189 | 0.03 ± 0.146 |
| Change from BL at Day 5 | 0.12 ± 0.163 | 0.11 ± 0.184 | 0.03 ± 0.161 |
| Change from BL at Day 6 | 0.08 ± 0.150 | 0.11 ± 0.195 | 0.03 ± 0.137 |
| Change from BL at Day 7 | 0.08 ± 0.158 | 0.10 ± 0.128 | 0.06 ± 0.138 |
| Change from BL at Day 8 | 0.12 ± 0.202 | 0.13 ± 0.124 | 0.01 ± 0.135 |
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 \[upper limit: \<470 msec\].
| milliseconds (msec) | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| PR: Baseline (BL) - Value at Visit | 170.2 ± 15.38 | 171.5 ± 13.87 | 165.8 ± 17.39 |
| PR: Change from BL at Day 1 | -3.6 ± 5.80 | -6.1 ± 7.37 | -2.7 ± 13.46 |
| PR: Change from BL at Day 2 | -3.9 ± 10.65 | -4.8 ± 11.93 | 4.4 ± 8.32 |
| PR: Change from BL at Day 8 | -2.1 ± 9.32 | -4.4 ± 9.43 | -1.0 ± 10.58 |
| RR: Baseline (BL) - Value at Visit | 966.7 ± 115.12 | 986.8 ± 106.40 | 971.6 ± 131.35 |
| RR: Change from BL at Day 1 | 43.9 ± 64.10 | 64.6 ± 113.36 | -6.0 ± 134.23 |
| RR: Change from BL at Day 2 | 19.6 ± 88.42 | 55.0 ± 97.58 | 66.7 ± 89.61 |
| RR: Change from BL at Day 8 | -1.3 ± 74.84 | -12.6 ± 71.04 | 9.9 ± 89.01 |
| QRS: Baseline (BL) - Value at Visit | 87.4 ± 8.79 | 88.9 ± 7.59 | 89.4 ± 8.93 |
| QRS: Change from BL at Day 1 | -0.1 ± 5.01 | 0.6 ± 3.66 | -4.4 ± 8.65 |
| QRS: Change from BL at Day 2 | 0.7 ± 5.01 | -0.7 ± 5.28 | -2.1 ± 5.78 |
| QRS: Change from BL at Day 8 | -0.6 ± 5.18 | -1.5 ± 4.93 | -1.7 ± 4.36 |
| QT: Baseline (BL) - Value at Visit | 414.7 ± 21.01 | 416.5 ± 18.51 | 411.9 ± 25.22 |
| QT: Change from BL at Day 1 | 5.9 ± 11.93 | 11.4 ± 15.44 | -9.7 ± 18.23 |
| QT: Change from BL at Day 2 | 0.5 ± 16.45 | 5.7 ± 16.12 | 11.9 ± 13.27 |
| QT: Change from BL at Day 8 | -2.6 ± 11.78 | -2.8 ± 10.71 | 1.6 ± 15.15 |
| QTcB: Baseline (BL) - Value at Visit | 422.3 ± 12.45 | 419.9 ± 15.40 | 418.7 ± 12.68 |
| QTcB: Change from BL at Day 1 | -3.3 ± 12.28 | -1.7 ± 12.72 | -7.9 ± 17.39 |
| QTcB: Change from BL at Day 2 | -3.4 ± 11.72 | -5.4 ± 10.99 | -2.1 ± 12.89 |
| QTcB: Change from BL at Day 8 | -2.4 ± 12.46 | -0.2 ± 11.90 | -0.6 ± 10.54 |
| QTcF: Baseline (BL) - Value at Visit | 419.5 ± 11.10 | 418.3 ± 12.85 | 415.9 ± 11.91 |
| QTcF: Change from BL at Day 1 | -0.2 ± 10.38 | 2.8 ± 8.50 | -8.5 ± 12.22 |
| QTcF: Change from BL at Day 2 | -2.1 ± 10.40 | -1.6 ± 8.82 | 2.8 ± 9.58 |
| QTcF: Change from BL at Day 8 | -2.7 ± 9.54 | -1.0 ± 9.11 | 0.1 ± 8.51 |
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.
| Beats per minute | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C |
|---|---|---|---|
| Baseline (BL) - Value at Visit | 62.3 ± 6.96 | 61.2 ± 6.71 | 62.4 ± 9.62 |
| Change from BL at Day 1 | -2.9 ± 3.89 | -4.1 ± 6.53 | 0.5 ± 8.36 |
| Change from BL at Day 2 | -1.0 ± 5.92 | -3.4 ± 6.03 | -4.6 ± 6.48 |
| Change from BL at Day 8 | -0.2 ± 5.31 | 0.8 ± 4.71 | -0.9 ± 6.35 |
Collected over From first dose of study drug until 14 days after the last dose of study drug (up to 41 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GDC-9545 Tablet, Fasted: Treatment A | 0/18 (0%) | 0/18 (0%) | 2/18 (11.1%) |
| GDC-9545 Capsule, Fasted: Treatment B | 0/18 (0%) | 0/18 (0%) | 2/18 (11.1%) |
| GDC-9545 Capsule, Fed: Treatment C | 0/18 (0%) | 0/18 (0%) | 3/18 (16.7%) |
| Overall: Any GDC-9545 Treatment (A, B, or C) | 0/18 (0%) | 0/18 (0%) | 5/18 (27.8%) |
| Event | GDC-9545 Tablet, Fasted: Treatment A | GDC-9545 Capsule, Fasted: Treatment B | GDC-9545 Capsule, Fed: Treatment C | Overall: Any GDC-9545 Treatment (A, B, or C) |
|---|---|---|---|---|
| HeadacheNervous system disorders | 0/18 | 2/18 | 0/18 | 2/18 |
| Dry eyeEye disorders | 1/18 | 0/18 | 0/18 | 1/18 |
| ConstipationGastrointestinal disorders | 1/18 | 0/18 | 0/18 | 1/18 |
| Skin abrasionInjury, poisoning and procedural complications | 0/18 | 0/18 | 1/18 | 1/18 |
| Blood creatine phosphokinase increasedInvestigations | 0/18 | 0/18 | 1/18 | 1/18 |
| CostochondritisMusculoskeletal and connective tissue disorders | 1/18 | 0/18 | 0/18 | 1/18 |
| Upper-airway cough syndromeRespiratory, thoracic and mediastinal disorders | 0/18 | 0/18 | 1/18 | 1/18 |
| FlushingVascular disorders | 1/18 | 0/18 | 0/18 | 1/18 |
| Age, Continuous(Years) | GDC-9545 Treatment Sequence A, B, and C | GDC-9545 Treatment Sequence B, C, and A | GDC-9545 Treatment Sequence C, A, and B | GDC-9545 Treatment Sequence A, C, and B | GDC-9545 Treatment Sequence B, A, and C | GDC-9545 Treatment Sequence C, B, and A | Total |
|---|---|---|---|---|---|---|---|
| Mean | 51.0 ± 4.4 | 55.0 ± 5.2 | 48.3 ± 8.1 | 54.0 ± 9.5 | 56.3 ± 5.9 | 53.7 ± 4.9 | 53.1 ± 6.2 |
| Sex: Female, Male(Participants) | GDC-9545 Treatment Sequence A, B, and C | GDC-9545 Treatment Sequence B, C, and A | GDC-9545 Treatment Sequence C, A, and B | GDC-9545 Treatment Sequence A, C, and B | GDC-9545 Treatment Sequence B, A, and C | GDC-9545 Treatment Sequence C, B, and A | Total |
|---|---|---|---|---|---|---|---|
| Female | 3 | 3 | 3 | 3 | 3 | 3 | 18 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | GDC-9545 Treatment Sequence A, B, and C | GDC-9545 Treatment Sequence B, C, and A | GDC-9545 Treatment Sequence C, A, and B | GDC-9545 Treatment Sequence A, C, and B | GDC-9545 Treatment Sequence B, A, and C | GDC-9545 Treatment Sequence C, B, and A | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 2 | 1 | 2 | 3 | 11 |
| Not Hispanic or Latino | 1 | 2 | 1 | 2 | 1 | 0 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | GDC-9545 Treatment Sequence A, B, and C | GDC-9545 Treatment Sequence B, C, and A | GDC-9545 Treatment Sequence C, A, and B | GDC-9545 Treatment Sequence A, C, and B | GDC-9545 Treatment Sequence B, A, and C | GDC-9545 Treatment Sequence C, B, and A | Total |
|---|---|---|---|---|---|---|---|
| White | 3 | 3 | 3 | 3 | 3 | 3 | 18 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Giredestrant