ISRCTN41455091Active, not recruitingPhase 1
A phase I, open-label, single-dose study to evaluate the effect of severe renal impairment on the pharmacokinetics of fenebrutinib
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Genentech, Inc
- Enrollment
- 16
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Male and female participants between 18 to 75 years of age, inclusive, at screening
- •2. Body weight =45 kilograms (kg) and within body mass index (BMI) range 18.0 to 42.0 kilograms per square meter (kg/m²), inclusive
- •Additional inclusion criteria for participants with normal renal function (Cohort 1) only:
- •1.In reasonably good health for their age
- •2. Estimated glomerular filtration rate (eGFR) determined using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation = 90 millilitres per minute (mL/min)
- •3. Matched to participants with severe renal impairment in sex, age (±10 years), and body weight (±15%)
- •Additional inclusion criteria for participants with severe renal impairment (Cohort 2) only:
- •Participants must have eGFR <30 mL/min and not be on dialysis and have stable renal function.
- •Other protocol defined inclusion criteria could apply.
Exclusion Criteria
- •1. Participants who are pregnant or breastfeeding or intending to become pregnant during the study or within 28 days after the dose of study drug.
- •2. Clinically significant liver disease, e.g., hepatitis, cirrhosis, and/or confirmed liver enzyme elevations (aspartate aminotransferase [AST], alanine aminotransferase [ALT], or gamma-glutamyl transferase >1.5 × upper limits of normal [ULN], or bilirubin >1.5 × ULN)
- •3. History of malignancy within 5 years prior to screening, except for completely excised basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ.
- •4. Significant illness, including infections, surgery, or hospitalization within the 2 weeks prior to dosing.
- •5. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that uncomplicated hernia repair, appendectomy, and/or cholecystectomy will be allowed.
- •6. Malabsorption syndrome or other conditions that would interfere with enteral absorption.
- •Additional exclusion criteria for participants with normal renal function (Cohort 1) only:
- •Significant history or clinical manifestation of renal injury or disease
- •Additional exclusion criteria for participants with severe renal impairment (Cohort 2) only:
- •1. Functioning renal transplant or who are active on the transplant waiting list.
- •2. Renal impairment due to hepatic disease (hepatorenal syndrome).
- •3. Blood potassium concentration <3 millimoles per litre (mmol/L) or >6 mmol/L at Screening.
- •4. Hemoglobin concentration <8.5 grams per decilitre (g/dL) at Screening.
- •Other protocol defined exclusion criteria could apply.
Investigators
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