A study to evaluate the effect of itraconazole and carbamazepine on the processing of fenebrutinib by the body in healthy participants

Phase 1

• Conditions: Healthy volunteers; Not Applicable

• Registration Number: ISRCTN12005942
• Lead Sponsor: Genentech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-20
• Last Update Posted: 8 July 2024
• Study Completion: 2024-09-03

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Body weight =45 kilograms (kg), within the body mass index range of 18 to 32 kilograms per metre squared (kg/m2).
2. Participants in good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs.

Exclusion Criteria

1. Part 2 only: Participants that test positive for human leukocyte antigen-B (HLA-B)*1502 allele and/or HLA-A 3101 allele
2. Participants who are pregnant or breastfeeding or intending to become pregnant during the study or within 28 days after the final dose of the study drug
3. Evidence of any infectious, metabolic (except well-controlled/stable hypothyroidism), allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder that would preclude subject participation
4. Any acute or chronic liver disease, e.g., hepatitis, cirrhosis (Child-Pugh Class A, B, or C), or Gilbert’s Syndrome
5. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy and hernia repair will be allowed
6. History of pancreatitis, cholecystectomy or gallstones, or clinically significant GI ulcer or bleeding
7. History of malignancy, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma with 5-year disease-free follow-up
8. Use of any moderate or strong CYP3A inhibitor or inducer within 30 days or 5 half-lives, whichever is longer, before Check-in (Period 1 Day -1)
9. Participants vaccinated with live, attenuated vaccines within 6 weeks before first dosing (Period 1 Day 1)
10. Dyspepsia, gastroesophageal reflux disease, ulcer, or GI symptoms for which the participant has recently taken (within 14 days before Check-in [Period 1 Day -1]) prescription or over-the-counter proton-pump inhibitors (PPIs), H2 blockers, or antacids for the control of gastric acidity

Study & Design

• Study Type: Interventional
• Study Design: Not specified