A phase I, open-label, single-dose, fixed-sequence, two-part study to evaluate the effect of itraconazole and carbamazepine on giredestrant pharmacokinetics in healthy female subjects of non-childbearing potential

Genentech0 sites33 target enrollmentMarch 14, 2024

ConditionsHealthy female participants Not Applicable

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy female participants
Sponsor: Genentech
Enrollment: 33
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 14, 2024

End Date

May 25, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Investigators

Sponsor

Genentech

Eligibility 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

•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\).