Healthy volunteers Not Applicable
Conditions
Interventions
Part 1: Participants will receive a single dose of fenebrutinib 100 milligrams (mg), orally, on Day 1 of Period 1. After a washout period of 3 days, participants will receive itraconazole 200 mg, oral
Sponsors
Genentech
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Parts 1 and 2: Maximum observed plasma concentration (Cmax) of fenebrutinib determined using a model-independent approach from samples collected at pre-dose and multiple time-points post-dose from Day 1 up to Day 11 in Part 1 and Day 1 up to Day 21 in Part 2 2. Parts 1 and 2: Time to maximum observed plasma concentration (tmax) of fenebrutinib determined using a model-independent approach from samples collected at pre-dose and multiple time-points post-dose from Day 1 up to Day 11 in Part 1 and Day 1 up to Day 21 in Part 2 3. Parts 1 and 2: Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC0-t) of fenebrutinib determined using a model-independent approach from samples collected at pre-dose and multiple time-points post-dose from Day 1 up to Day 11 in Part 1 and Day 1 up to Day 21 in Part 2 4. Parts 1 and 2: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-8) of fenebrutinib determined using a model-independent approach from samples collected at pre-dose and multiple time-points post-dose from Day 1 up to Day 11 in Part 1 and Day 1 up to Day 21 in Part 2 5. Parts 1 and 2: Apparent terminal elimination rate constant (?z) of fenebrutinib determined using a model-independent approach from samples collected at pre-dose and multiple time-points post-dose from Day 1 up to Day 11 in Part 1 and Day 1 up to Day 21 in Part 2 6. Parts 1 and 2: Apparent terminal elimination half-life (t1/2) of fenebrutinib determined using a model-independent approach from samples collected at pre-dose and multiple time-points post-dose from Day 1 up to Day 11 in Part 1 and Day 1 up to Day 21 in Part 2 7. Parts 1 and 2: Apparent systemic clearance (CL/F) of fenebrutinib determined using a model-independent approach from samples collected at pre-dose and multiple time-points post-dose from Day 1 up to Day 11 in Part 1 and Day 1 up to Day 21 in Part 2 8. Parts 1 and 2: Apparent volume of distr | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Parts 1 and 2: Number of participants with adverse events (AEs) and severity of AEs determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) from screening to end of treatment (approximately 50 days for Part 1 and 60 days for Part 2) | — |
Countries
England, United Kingdom
Contacts
Public ContactClinical Trials
Outcome results
None listed