None listed
Conditions
Brief summary
This Phase 1 study aims to evaluate, characterize, and compare the PK and short-term safety profile of single-dose orally administered lenabasum in subjects with varying degrees of renal impairment and in matched control subjects with age-appropriate renal function. The data generated from this study may allow subjects with a broader range of renal function to enter future studies and eventually receive this medication should it be approved for use by regulatory authorities.
Interventions
Investigational Product: lenabasum (CB2 agonist)
Subjects with mild, moderate and severe renal impairment will be enrolled, along with matched control subjects. All subjects will receive a single, oral capsule dose of lenabasum 20 mg. A hand and mouth check will be done after dose administration. The study will compare the PK of lenabasum in adults with mild, moderate and severe renal impairment to that in the matched controls. Matched controls will be subjects with age-appropriate renal functi
Investigational Product: lenabasum (CB2 agonist) Subjects with mild, moderate and severe renal impairment will be enrolled, along with matched control subjects. All subjects will receive a single, oral capsule dose of lenabasum 20 mg. A hand and mouth check will be done after dose administration. The study will compare the PK of lenabasum in adults with mild, moderate and severe renal impairment to that in the matched controls. 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.
Sponsors
Corbus Pharmaceuticals Inc
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• 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: o Severe: less than 30 o Moderate:30- 59 o Mild: 60-89 o Matched: 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: o age (±10 years) o body weight (±20%) o sex o race (if possible)
Exclusion criteria
• 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
Outcome results
None listed