Healthy female participants Not Applicable
Conditions
Interventions
Participants will be assigned to either Part A or Part B of the study. Each part consisted of 2 periods.
Part A - Period 1: Participants received giredestrant, 10 mg, orally, on Day 1 of Period 1.
Sponsors
Genentech
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Females of non-childbearing potential and either postmenopausal and with a negative pregnancy test result at screening (serum test) and check-in (Day -1; urine test) of Period 1. 2. Females with body mass index (BMI) range 18.5 to 32.0 kilograms per meter square (kg/m2), inclusive, at screening. 3. Females in good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), or vital signs. 4. Negative hepatitis panel (hepatitis B surface antigen and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens.
Exclusion criteria
Exclusion criteria: 1. Female participant with a significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the investigator). 2. History of stomach or intestinal surgery (including cholecystectomy) or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and hernia repair were allowed (unless performed within 12 months prior to screening). 3. Malabsorption syndrome or other condition that would interfere with enteral absorption. 4. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance < 70 milliliters/minute (mL/min) using the Cockcroft-Gault equation. 5. History of active or latent tuberculosis (TB), regardless of treatment history, or positive QuantiFERON TB Gold test. 6. History of previous use of tamoxifen, aromatase inhibitors, giredestrant, or any other endocrine agent for the treatment of breast cancer. 7. The use of hormone replacement therapy or selective estrogen receptor (ER) modulators (selective estrogen receptor modulators (SERMs); e.g., raloxifene) within 1 year prior to Check-in (Day -1) or 8. The use of oral antibiotics within 4 weeks or intravenous (IV) antibiotics within 8 weeks prior to check-in (Day -1). 9. Use of any moderate or strong cytochrome P450 (CYP3A) inhibitor or inducer within 30 days or 5 half-lives, whichever is longer, prior to Check-in (Day-1). 10. The use or intent to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John’s wort, within 30 days prior to Check-in (Day -1). 11. Female subject having a history of any malignancy, within 5 years prior to screening. 12. Positive for the human leukocyte antigen-B (HLA-B*1502) allele (Part B only).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Part A: Maximum observed concentration (Cmax) of giredestrant in plasma determined using the non-compartmental analysis approach from samples collected at predose and multiple time points post-dose from Day 1 up to Day 8 in Period 1 and Day 4 up to Day 15 in Period 2 of Part A 2. Part A: Time to maximum observed concentration (tmax) of giredestrant in plasma determined using the non-compartmental analysis approach from samples collected at predose and multiple time points post-dose from Day 1 up to Day 8 in Period 1 and Day 4 up to Day 15 in Period 2 of Part A 3. Part A: Area under the concentration-time curve from hour 0 to last measurable concentration (AUC0-t) of giredestrant in plasma determined using the non-compartmental analysis approach from samples collected at predose and multiple time points post-dose from Day 1 up to Day 8 in Period 1 and Day 4 up to Day 15 in Period 2 of Part A 4. Part A: Area under the concentration-time curve extrapolated to infinity (AUC 0-8) of giredestrant in plasma determined using the non-compartmental analysis approach from samples collected at predose and multiple time points post-dose from Day 1 up to Day 8 in Period 1 and Day 4 up to Day 15 in Period 2 of Part A 5. Part A: Apparent terminal elimination rate constant (?z) of giredestrant in plasma determined using the non-compartmental analysis approach from samples collected at predose and multiple time points post-dose from Day 1 up to Day 8 in Period 1 and Day 4 up to Day 15 in Period 2 of Part A 6. Part A: Apparent terminal elimination half-life (t1/2) of giredestrant in plasma determined using the non-compartmental analysis approach from samples collected at predose and multiple time points post-dose from Day 1 up to Day 8 in Period 1 and Day 4 up to Day 15 in Period 2 of Part A 7. Part A: Apparent total clearance (CL/F) of giredestrant determined using the non-compartmental analysis approach from samples collected at predose and multiple time points p | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Part A: Number of participants with adverse events (AEs) and severity of AEs determined according to National Cancer Institute Common Terminology Criteria For Adverse Events (NCI CTCAE) from Day 1 up to follow-up (up to approximately 35 days) 2. Part B: Number of participants with AEs and severity of AEs determined according to NCI CTCAE from Day 1 up to follow-up (up to approximately 40 days) 3. Part B: Number of participants with suicidal ideation or behavior, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) score from screening up to follow-up (up to approximately 75 days) | — |
Countries
United States of America
Contacts
Public ContactClinical Trials
Outcome results
None listed