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 hepatic impairment and in matched healthy control subjects with normal hepatic function. The data generated from this study may allow subjects with a broader range of hepatic 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 hepatic impairment will be enrolled, along with matched healthy control subjects. All subjects will receive a single, oral capsule 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 hepatic impairment to that in the matched controls.
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 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: o have stable chronic hepatic impairment with liver cirrhosis for at least 3 months o meet 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 o meet all of the following laboratory parameters at Screening: o Alanine aminotransferase less than or equal to 10 × ULN o Bilirubin less than or equal to 100 µmol/L o International normalized ratio <2.5 o Absolute neutrophil count greater than or equal to 1.0 × 109/L o Platelet counts greater than or equal to 30 × 109/L o Hemoglobin greater than or equal to 90 g/L o a-fetoprotein less than or equal to 50 µg/L o Glycated hemoglobin A1c <9% or equivalent (eg, <75 mmol/mol). Control subjects should be matched to a subject with hepatic impairment in terms of: o age (±10 years) o body weight (±20%) o sex o race (if possible)
Exclusion criteria
• 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
Outcome results
None listed