A study to evaluate the effects of multiple doses of itraconazole and carbamazepine on processing of giredestrant by the body in healthy female participants

Phase 1

Completed

• Conditions: Healthy female participants; Not Applicable

• Registration Number: ISRCTN16366416
• Lead Sponsor: Genentech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-05-25
• Study Start: 2024-03-14
• Last Update Posted: 25 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 33

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).
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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified