Multiple sclerosis (MS) (study conducted in volunteers with normal renal function or severe renal impairment) Not Applicable
Conditions
Interventions
Cohort 1: Participants with normal renal function will receive a single dose of fenebrutinib, 200 milligrams (mg), orally on Day 1.
Cohort 2: Participants with severe renal impairment will receive a
Sponsors
Genentech, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 6 mmol/L at Screening. 4. Hemoglobin concentration <8.5 grams per decilitre (g/dL) at Screening. Other protocol defined exclusion criteria could apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Area under the concentration-time curve (AUC) from hour zero to the last measurable concentration (AUC0-t) of fenebrutinib measured using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay from the plasma samples collected at multiple time points, from Day 1 to Day 4 2. AUC extrapolated to infinity (AUC 0-8) of fenebrutinib measured using a validated LC-MS/MS assay from the plasma samples collected at multiple time points, from Day 1 to Day 4 3. Maximum observed concentration (Cmax) of fenebrutinib measured using a validated LC-MS/MS assay from the plasma samples collected at multiple time points, from Day 1 to Day 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of participants with adverse events (AEs), and severity of AEs assessed according to National Cancer Institute Common Terminology Criteria For Adverse Events, version 5.0 (NCI CTCAE v5.0), from screening up to 14 days after the dose of study drug (approximately 6 weeks) | — |
Countries
New Zealand
Contacts
Public ContactClinical Trials
Outcome results
None listed