A Phase 1, 2-part, Single-dose, Non-Randomized, Open-label, Parallel-group Study to Assess the Pharmacokinetics and Safety of Lenabasum in Subjects with Renal Impairment Compared with Matched Controls

Corbus Pharmaceuticals Inc0 个研究点目标入组 16 人开始时间: 2020年7月2日最近更新: 2021年10月26日

适应症

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•Male and female subjects aged greather than or equal to 18 years at Screening with suitable veins for cannulation or repeated venipuncture
•Subjects must meet the respective estimated creatinine clearance (mL/min) criteria for renal impairment:
•oSevere: less than 30
•oModerate:30- 59
•oMild: 60-89
•oMatched: greater than or equal to 60 (Matched controls will be subjects with age-appropriate renal function. This group may include both subjects with FDA-defined normal renal function (GFR greater than 90) and subjects with physiologically age-appropriate decline in renal function (GRF 60-90) who are relatively healthy)
•Stable renal function over the preceding 3-6 months
•Stable and well-controlled comorbidities
•Matched subjects should be in the range of:
•oage (±10 years)
•obody weight (±20%)
•orace (if possible)

•Subjects with acute renal disease and/or history of renal transplant.
•Have had a kidney transplant, or are on dialysis.
•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
•Have a history of alcohol or drug abuse / addiction (including cannabis) in the last five years.
•Are a regular user of nicotine products (e.g. you 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.
•Have uncontrolled hypertension
•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.
•Known hypersensitivity to lenabasum or any of its excipients.
•Participation in any other clinical study

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