A Study to Evaluate the Effect of Hepatic Impairment on JNJ-73763989
- Registration Number
- NCT04208386
- Lead Sponsor
- Janssen Sciences Ireland UC
- Brief Summary
The purpose of the study is to evaluate the single-dose pharmacokinetic (PK) of JNJ-73763976 and JNJ-73763924 following a subcutaneous (SC) injection of JNJ-73763989 (JNJ-3989) in participants with liver cirrhosis and various degrees of impaired hepatic function when compared with healthy participants with normal hepatic function and no liver cirrhosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
Not provided
Exclusion Criteria
- History of/or current clinically significant medical illness that could interfere with the interpretation of the study results.
- Known allergies, hypersensitivity, or intolerance to JNJ-3989 or its excipients.
- History of drug or alcohol abuse within 1 year before screening or positive test results at screening and Day -1.
- Blood or blood products donated or substantial loss of blood (more than 500 milliliters [mL]) within 3 months before the study starts
- Experimental drug received (including investigational vaccines) or experimental medical device used within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study intervention is scheduled.
- Evidence of infection with Human Immunodeficiency Virus (HIV)-1 and HIV-2, hepatitis A, B or C (except if sustained virologic response to HCV treatment)
- Inability to fast for 10 hours
- Signs of hepatocellular carcinoma or history of biliary obstruction within the past 2 years
- Lack of good or reasonable venous access
- Use of any disallowed therapies as per protocol
- Participants with advanced renal disease with staggered estimated glomerular filtration rate (eGFR) cutoff for increasing degree of hepatic impairment
- History of Liver transplant, gastroesophageal variceal bleeding within 6 months prior to screening, known gastric varices, uncontrolled ascites, spontaneous bacterial peritonitis within 3 months before screening
- Acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function or use of any therapy known to exacerbate hepatic dysfunction within 2 weeks of study intervention administration
- Clinically significant laboratory findings except as related to hepatic impairment as defined per protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: Group 1 JNJ-73763989 Participants with liver cirrhosis with moderate hepatic impairment will receive single subcutaneous (SC) injection of JNJ-73763989 on Day 1 under fasted condition. Part A: Group 2 JNJ-73763989 Participants with normal liver function with no liver cirrhosis will receive single SC injection of JNJ-73763989 on Day 1 under fasted condition. Part B: Group 3 (optional) JNJ-73763989 Participants with liver cirrhosis with mild hepatic impairment will receive single SC injection of JNJ-73763989 on Day 1 under fasted condition. Part B: Group 4 (optional) JNJ-73763989 Participants with liver cirrhosis with severe hepatic impairment will receive SC injection of JNJ-73763989 on Day 1 under fasted condition.
- Primary Outcome Measures
Name Time Method Plasma Concentration of JNJ-73763989 Up to Day 4 Plasma concentration of oral dose of JNJ-73763989 will be reported.
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and Tolerability Up to 42 days An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Trial Locations
- Locations (1)
CRS Clinical Research Services Kiel GmbH
🇩🇪Kiel, Germany