ISRCTN12005942
Active, not recruiting
Phase 1
A Phase I, open-label, single-dose, fixed-sequence, two-part study to evaluate the effect of itraconazole and carbamazepine on fenebrutinib pharmacokinetics in healthy subjects
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy volunteers
- Sponsor
- Genentech
- Enrollment
- 32
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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