A Phase 1, Single-dose, Non-Randomized, Open-label, Parallel-group Study to Assess the Pharmacokinetics and Safety of Lenabasum in Subjects with Hepatic Impairment Compared with Matched Healthy Controls

Corbus Pharmaceuticals Inc0 个研究点目标入组 32 人开始时间: 2020年6月30日最近更新: 2020年7月20日

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•Male and female subjects aged greater than or equal to 18 years at Screening with suitable veins for cannulation or repeated venipuncture
•Healthy or have stable and well-controlled comorbidities
•Subjects with Hepatic Impairment must:
•ohave stable chronic hepatic impairment with liver cirrhosis for at least 3 months
•omeet the impairment criteria for the group they are enrolled (mild equals Child-Pugh Class A, moderate equals Child-Pugh Class B, or severe equals Child Pugh Class C) at screening
•omeet all of the following laboratory parameters at Screening:
•oAlanine aminotransferase less than or equal to 10 × ULN
•oBilirubin less than or equal to 100 µmol/L
•oInternational normalized ratio <2.5
•oAbsolute neutrophil count greater than or equal to 1.0 × 109/L
•oPlatelet counts greater than or equal to 30 × 109/L
•oHemoglobin greater than or equal to 90 g/L
•oa-fetoprotein less than or equal to 50 µg/L
•oGlycated hemoglobin A1c <9% or equivalent (eg, <75 mmol/mol).
•Control subjects should be matched to a subject with hepatic impairment in terms of:
•oage (±10 years)
•obody weight (±20%)
•orace (if possible)

•History of diseases or surgeries of the gastrointestinal tract.
•Have had cancer in the last three years (some treated skin cancers are permitted).
•Have a current infection, or infections that keep coming back despite treatment
•History of any other medical, psychiatric, or substance abuse condition, concurrent medical therapies, or abnormal laboratory values that in the opinion of the Investigator may put the subject at greater safety risk, influence response to study drug, or interfere with study assessments.
•Known hypersensitivity to lenabasum or any of its excipients.
•Have an estimated creatinine clearance <50 mL/min at Screening using the Cockcroft Gault formula.
•Have uncontrolled hypertension
•Are a regular user of nicotine products (e.g. smoke more than 10 cigarettes per day).
•Have an average alcohol intake of more than 10 drinks per week (women) or 15 drinks / week (men). One drink equals 360 mL beer, 150 mL wine, or 45 mL spirits.
•Use of medications which are known strong cytochrome P450 isoenzyme substrates/inducers/inhibitors within 30 days prior to study dosing and for the duration of the study.
•Participation in any other clinical study
•Additional criterion apply for subjects with hepatic impairment, including but not limited to:
•Presence of severe hepatic encephalopathy of Grade 3 or 4
•Presence of acute liver disease
•History of liver transplant

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