Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).

Mass Balance Population, Part 1: all participants who received a dose of study drug, had evaluable total radioactivity concentration (urinary and fecal) data, and had no protocol deviations that affected the mass balance analysis (e.g., spillage or missing collections, or vomiting).

Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).

Mass Balance Population, Part 1: all participants who received a dose of study drug, had evaluable total radioactivity concentration (urinary and fecal) data, and had no protocol deviations that affected the mass balance analysis (e.g., spillage or missing collections, or vomiting).

Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).

Mass Balance Population, Part 1: all participants who received a dose of study drug, had evaluable total radioactivity concentration (urinary and fecal) data, and had no protocol deviations that affected the mass balance analysis (e.g., spillage or missing collections, or vomiting). Only urine samples were collected over 2 intervals in the first 24 hours postdose: 0-12 hours and 12-24 hours; fecal samples were collected over a single 0-24 hours interval.

Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).

Mass Balance Population, Part 1: all participants who received a dose of study drug, had evaluable total radioactivity concentration (urinary and fecal) data, and had no protocol deviations that affected the mass balance analysis (e.g., spillage or missing collections, or vomiting).

Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).

Mass Balance Population, Part 1: all participants who received a dose of study drug, had evaluable total radioactivity concentration (urinary and fecal) data, and had no protocol deviations that affected the mass balance analysis (e.g., spillage or missing collections, or vomiting). Only urine samples were collected over 2 intervals in the first 24 hours postdose: 0-12 hours and 12-24 hours; fecal samples were collected over a single 0-24 hours interval.

Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).

Mass Balance Population, Part 1: all participants who received a dose of study drug, had evaluable total radioactivity concentration (urinary and fecal) data, and had no protocol deviations that affected the mass balance analysis (e.g., spillage or missing collections, or vomiting).

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting. The unit of measure for the total radioactivity concentrations is nanogram equivalent of free drug per millilitre.

Pharmacokinetics (PK) Population, Part 1: all participants who received at least one dose and who satisfied the following criteria for at least one PK profile: no missing samples or invalid results at critical timepoints; no relevant protocol deviations; and, no relevant adverse events (such as vomiting).

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.

Pharmacokinetics (PK) Population, Part 1: all participants who received at least one dose and who satisfied the following criteria for at least one PK profile: no missing samples or invalid results at critical timepoints; no relevant protocol deviations; and, no relevant adverse events (such as vomiting).

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.

Pharmacokinetics (PK) Population, Part 1: all participants who received at least one dose and who satisfied the following criteria for at least one PK profile: no missing samples or invalid results at critical timepoints; no relevant protocol deviations; and, no relevant adverse events (such as vomiting).

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.

Pharmacokinetics (PK) Population, Part 1: all participants who received at least one dose and who satisfied the following criteria for at least one PK profile: no missing samples or invalid results at critical timepoints; no relevant protocol deviations; and, no relevant adverse events (such as vomiting).

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity (TR) concentrations in plasma and whole blood were determined using liquid scintillation counting.

Pharmacokinetics (PK) Population, Part 1: all participants who received at least one dose and who satisfied the following criteria for at least one PK profile: no missing samples or invalid results at critical timepoints; no relevant protocol deviations; and, no relevant adverse events (such as vomiting). 3 participants in the TR in plasma group were excluded from analysis because their parameter estimates were considered unreliable (i.e., extrapolated portion was >20% of total).

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity (TR) concentrations in plasma and whole blood were determined using liquid scintillation counting.

Pharmacokinetics (PK) Population, Part 1: all participants who received at least one dose and who satisfied the following criteria for at least one PK profile: no missing samples or invalid results at critical timepoints; no relevant protocol deviations; and, no relevant adverse events (such as vomiting). 3 participants in the TR in whole blood group were excluded from analysis because their parameter estimates were considered unreliable (i.e., coefficient of regression for terminal slope <0.9).

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.

Pharmacokinetics (PK) Population, Part 1: all participants who received at least one dose and who satisfied the following criteria for at least one PK profile: no missing samples or invalid results at critical timepoints; no relevant protocol deviations; and, no relevant adverse events (such as vomiting). 3 participants in the TR in whole blood group were excluded from analysis because their parameter estimates were considered unreliable (i.e., coefficient of regression for terminal slope <0.9).

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.

Pharmacokinetics (PK) Population, Part 1: all participants who received at least one dose and who satisfied the following criteria for at least one PK profile: no missing samples or invalid results at critical timepoints; no relevant protocol deviations; and, no relevant adverse events (such as vomiting).

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.

Pharmacokinetics (PK) Population, Part 1: all participants who received at least one dose and who satisfied the following criteria for at least one PK profile: no missing samples or invalid results at critical timepoints; no relevant protocol deviations; and, no relevant adverse events (such as vomiting).

Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting. For calculation of the geometric mean, values reported as not detectable have been set to 0.5× the limit of detection (LOD); the LOD was 11.0 nanogram equivalent of free drug per millilitre (mL).

Pharmacokinetics (PK) Population, Part 1: all participants who received at least one dose and who satisfied the following criteria for at least one PK profile: no missing samples or invalid results at critical timepoints; no relevant protocol deviations; and, no relevant adverse events (such as vomiting).

Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting. The limit of detection was 11.0 nanogram equivalent of free drug per millilitre (mL).

Pharmacokinetics (PK) Population, Part 1: all participants who received at least one dose and who satisfied the following criteria for at least one PK profile: no missing samples or invalid results at critical timepoints; no relevant protocol deviations; and, no relevant adverse events (such as vomiting). Participants were excluded from analysis at a given timepoint if total radioactivity was not detected in either their plasma or whole blood samples at that timepoint.

Absolute bioavailability of the GDC-9545/F12 and /F18 capsules were calculated relative to GDC-9545 solution for infusion based on the adjusted geometric mean AUC(0-∞) values obtained after oral and intravenous (IV) administration of GDC-9545. Log-transformed AUC(0-∞) was analyzed using mixed effects modelling techniques. The model included terms for treatment and sequence fitted as fixed effects and subject within sequence fitted as a random effect.

Part 2 Pharmacokinetics (PK) Population Subset: all participants who received Treatments B and C or B and D and had reliable estimates of PK parameters for the assessment of relative bioavailability. One participant was excluded from analysis for both Treatments C and D because they did not have reliable estimates (i.e., pre-dose concentrations of GDC-9545 that were >5% of Cmax).

Relative bioavailability of the GDC-9545/F18 capsule was calculated relative to the GDC-9545/F12 capsule based on the adjusted geometric mean Cmax values. Log-transformed Cmax was analyzed using mixed effects modelling techniques. The model included terms for treatment, sequence, and period fitted as fixed effects and subject nested within sequence as a random effect.

Part 2 Pharmacokinetics (PK) Population Subset: all participants who received Treatments C and D and had reliable estimates of PK parameters for the assessment of relative bioavailability. One participant was excluded from analysis because they did not have a reliable estimate (i.e., pre-dose concentration of GDC-9545 that was >5% of Cmax).

Relative bioavailability of the GDC-9545/F18 capsule was calculated relative to the GDC-9545/F12 capsule based on the adjusted geometric mean AUC(0-∞) values. Log-transformed AUC(0-∞) was analyzed using mixed effects modelling techniques. The model included terms for treatment, sequence, and period fitted as fixed effects and subject nested within sequence as a random effect.

Part 2 Pharmacokinetics (PK) Population Subset: all participants who received Treatments C and D and had reliable estimates of PK parameters for the assessment of relative bioavailability. One participant was excluded from analysis because they did not have a reliable estimate (i.e., pre-dose concentration of GDC-9545 that was >5% of Cmax).

Relative bioavailability of the GDC-9545/F18 capsule was calculated relative to the GDC-9545/F12 capsule based on the adjusted geometric mean AUC(0-t) values. Log-transformed AUC(0-t) was analyzed using mixed effects modelling techniques. The model included terms for treatment, sequence, and period fitted as fixed effects and subject nested within sequence as a random effect.

Part 2 Pharmacokinetics (PK) Population Subset: all participants who received Treatments C and D and had reliable estimates of PK parameters for the assessment of relative bioavailability. One participant was excluded from analysis because they did not have a reliable estimate (i.e., pre-dose concentration of GDC-9545 that was >5% of Cmax).

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.

Pharmacokinetics (PK) Population, Part 2: all participants who received at least one dose and who satisfied the criteria for at least one PK profile. One participant was excluded from the PK analysis set for both Treatments C and D, owing to their having quantifiable pre-dose concentrations of GDC-9545 that were >5% of Cmax for both treatments.

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.

Pharmacokinetics (PK) Population, Part 2: all participants who received at least one dose and who satisfied the criteria for at least one PK profile. One participant was excluded from the PK analysis set for both Treatments C and D, owing to their having quantifiable pre-dose concentrations of GDC-9545 that were >5% of Cmax for both treatments.

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.

Pharmacokinetics (PK) Population, Part 2: all participants who received at least one dose and who satisfied the criteria for at least one PK profile. One participant was excluded from the PK analysis set for both Treatments C and D, owing to their having quantifiable pre-dose concentrations of GDC-9545 that were >5% of Cmax for both treatments.

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.

Pharmacokinetics (PK) Population, Part 2: all participants who received at least one dose and who satisfied the criteria for at least one PK profile. One participant was excluded from the PK analysis set for both Treatments C and D, owing to their having quantifiable pre-dose concentrations of GDC-9545 that were >5% of Cmax for both treatments, and 1 participant was excluded from Treatment B analysis for having an unreliable AUC(0-∞) estimate (i.e., extrapolated portion >20% of total).

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.

Pharmacokinetics (PK) Population, Part 2: all participants who received at least one dose and who satisfied the criteria for at least one PK profile. One participant was excluded from the PK analysis set for both Treatments C and D, owing to their having quantifiable pre-dose concentrations of GDC-9545 that were >5% of Cmax for both treatments.

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.

Pharmacokinetics (PK) Population, Part 2: all participants who received at least one dose and who satisfied the criteria for at least one PK profile. One participant was excluded from the PK analysis set for both Treatments C and D, owing to their having quantifiable pre-dose concentrations of GDC-9545 that were >5% of Cmax for both treatments.

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.

Pharmacokinetics (PK) Population, Part 2: all participants who received at least one dose and who satisfied the criteria for at least one PK profile. One participant was excluded from the PK analysis set because the AUC(0-∞) estimate was considered unreliable (i.e., extrapolated portion was >20% of total).

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.

Pharmacokinetics (PK) Population, Part 2: all participants who received at least one dose and who satisfied the criteria for at least one PK profile. One participant was excluded from the PK analysis set for both Treatments C and D, owing to their having quantifiable pre-dose concentrations of GDC-9545 that were >5% of Cmax for both treatments.

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.

Pharmacokinetics (PK) Population, Part 2: all participants who received at least one dose and who satisfied the criteria for at least one PK profile. One participant was excluded from the PK analysis set because the AUC(0-∞) estimate was considered unreliable (i.e., extrapolated portion was >20% of total).

Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.

Pharmacokinetics (PK) Population, Part 2: all participants who received at least one dose and who satisfied the criteria for at least one PK profile. One participant was excluded from the PK analysis set for both Treatments C and D, owing to their having quantifiable pre-dose concentrations of GDC-9545 that were >5% of Cmax for both treatments.

All adverse events (AEs) were recorded and the investigator independently assessed the seriousness and severity of each AE. AE severity was graded on a scale from 1 to 5 using the NCI-CTCAE v5.0; any events not specifically listed in the scale were defined as: 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. AEs of special interest were: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law; Cases of potential drug-induced kidney injury; Grade ≥3 nausea/vomiting/diarrhea; Grade ≥2 thromboembolic events; Grade ≥3 renal failure; Grade ≥3 hepatitis or elevation in ALT or AST; Grade ≥2 vaginal or uterine hemorrhage; Grade ≥2 bradycardia; Any grade of endometrial cancer; and, Suspected transmission of an infectious agent by the study drug.

Safety Population: all participants who received at least one dose of study drug, grouped according to the treatment received.

Participants provided blood samples at the specified timepoints for laboratory analysis of clinical chemistry, hematology, and coagulation panels (please refer to Appendices 1 and 2 of the protocol for a complete list). Any of the laboratory test results that were outside of a parameter's normal 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.

Safety Population: all participants who received at least one dose of study drug, grouped according to the treatment received.

Vital sign measurements included pulse rate, systolic and diastolic blood pressure while the participant was in a supine position for 5 minutes, and oral temperature. Any of the vital sign results that were outside of a parameter's normal range were considered abnormalities. Not every vital sign abnormality qualified as an adverse event (AE). A vital sign 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.

Safety Population: all participants who received at least one dose of study drug, grouped according to the treatment received.

The 12-lead electrocardiograms (ECG) recorded measurements of heart rate, and PR, RR, QRS, uncorrected QT, and QTcF intervals. Any of the ECG parameter results that were outside of the normal range were considered abnormalities. Not every ECG abnormality qualified as an adverse event (AE). An ECG 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.

Safety Population: all participants who received at least one dose of study drug, grouped according to the treatment received.