A 2-Part Study of the Pharmacokinetics and Safety of a Single Dose of Lenabasum in Subjects with Renal Impairment Compared with Matched Controls
- Conditions
- Renal impairmentRenal insufficiencyRenal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12620000717954
- Lead Sponsor
- Corbus Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 16
•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%)
osex
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration-time profiles and pharmacokinetics of lenabasum in terms of Cmax and AUC[Up to 48 hours post-dose as specified below:<br>Day andTime Point Relative to Dosing<br>Day 1Predose<br>30 min postdose<br>1 h postdose<br>1.5 h postdose<br>2 h postdose<br>2.5 h postdose<br>3 h postdose<br>3.5 h postdose<br>4 h postdose<br>5 h postdose<br>6 h postdose<br>8 h postdose<br>12 h postdose<br>Day 224 h postdose<br>36 h postdose<br>Day 348 h postdose<br>]
- Secondary Outcome Measures
Name Time Method