A Study to Evaluate the Effect of Hepatic Impairment on JNJ-73763989

• Sponsor: Janssen Sciences Ireland UC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04208386
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 4
• Actual Duration (Months): 6.4
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Impairment	Drug: JNJ-73763989	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of JNJ-73763989
• Actual Study Start Date: Jan 8, 2020
• Actual Primary Completion Date: Jul 20, 2020
• Actual Study Completion Date: Jul 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A: Group 1 Participants with liver cirrhosis with moderate hepatic impairment will receive single subcutaneous (SC) injection of JNJ-73763989 on Day 1 under fasted condition.	Drug: JNJ-73763989; JNJ-73763989 will be administered SC under fasted condition.
Experimental: Part A: Group 2 Participants with normal liver function with no liver cirrhosis will receive single SC injection of JNJ-73763989 on Day 1 under fasted condition.	Drug: JNJ-73763989; JNJ-73763989 will be administered SC under fasted condition.
Experimental: Part B: Group 3 (optional) Participants with liver cirrhosis with mild hepatic impairment will receive single SC injection of JNJ-73763989 on Day 1 under fasted condition.	Drug: JNJ-73763989; JNJ-73763989 will be administered SC under fasted condition.
Experimental: Part B: Group 4 (optional) Participants with liver cirrhosis with severe hepatic impairment will receive SC injection of JNJ-73763989 on Day 1 under fasted condition.	Drug: JNJ-73763989; JNJ-73763989 will be administered SC under fasted condition.

Outcome Measures

Primary Outcome Measures

1. Plasma Concentration of JNJ-73763989 [Up to Day 4]

   Plasma concentration of oral dose of JNJ-73763989 will be reported.

Secondary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

• For all participants: Body mass index (BMI) between 18.0 and 38 kilogram per meter square (kg/m^2), (extremes included), and a body weight not less than 50 kilograms (kg) at screening; Woman of childbearing potential must not be pregnant; Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential; Non-smoker or light smoker as defined per protocol

• For Healthy Participants with Normal Hepatic Function and No Liver Cirrhosis: Demographically comparable to the study groups with hepatic impairment with respect to sex, age (+/-10 years), and body weight (+/-10 kg); Participants must be in good health clinically and biologically as defined per protocol

• For Participants with Liver Cirrhosis and Moderate or Mild or Severe Hepatic Impairment: Must have a total Child-Pugh score of 5 or 6, inclusive (mild); or 7 to 9, inclusive (moderate); or 10 to 15, inclusive (severe) as determined by the investigator; Must have liver cirrhosis with fibro scan readout greater than (>) 12.5 Kilopascal (kPa) as cut-off at screening

• Participants with controlled hypertension, with problems directly associated with the primary diagnosis of hepatic impairment may be included. Participants may have concurrent stable medical conditions and may be included in the study if the investigator and the sponsor consider that the condition(s) will not introduce an additional risk factor and will not interfere with the study objectives and the procedures (that is, participants with mild degenerative joint disease, controlled diabetes, controlled thyroid conditions, other conditions addressed on a case by case basis)

• Concomitant medications to treat underlying disease states or medical conditions related to hepatic impairment are allowed

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRS Clinical Research Services Kiel GmbH	Kiel		Germany	24105

Sponsors and Collaborators

• Janssen Sciences Ireland UC

Investigators

• Study Director: Janssen Sciences Ireland UC Clinical Trial, Janssen Sciences Ireland UC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen Sciences Ireland UC
• ClinicalTrials.gov Identifier: NCT04208386
• Other Study ID Numbers: CR108708; 73763989HPB1002; 2019-003083-51
• First Posted: Dec 23, 2019
• Last Update Posted: Sep 30, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Liver Diseases

Study Results

No Results Posted as of Sep 30, 2020