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

Primary Purpose

Hepatic Impairment

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
JNJ-73763989
Sponsored by
Janssen Sciences Ireland UC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CRS Clinical Research Services Kiel GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Part A: Group 1

Part A: Group 2

Part B: Group 3 (optional)

Part B: Group 4 (optional)

Arm Description

Participants with liver cirrhosis with moderate hepatic impairment will receive single subcutaneous (SC) injection of JNJ-73763989 on Day 1 under fasted condition.

Participants with normal liver function with no liver cirrhosis will receive single SC injection of JNJ-73763989 on Day 1 under fasted condition.

Participants with liver cirrhosis with mild hepatic impairment will receive single SC injection of JNJ-73763989 on Day 1 under fasted condition.

Participants with liver cirrhosis with severe hepatic impairment will receive SC injection of JNJ-73763989 on Day 1 under fasted condition.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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.

Full Information

First Posted
December 20, 2019
Last Updated
September 29, 2020
Sponsor
Janssen Sciences Ireland UC
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1. Study Identification

Unique Protocol Identification Number
NCT04208386
Brief Title
A Study to Evaluate the Effect of Hepatic Impairment on JNJ-73763989
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
July 20, 2020 (Actual)
Study Completion Date
July 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Sciences Ireland UC

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: Group 1
Arm Type
Experimental
Arm Description
Participants with liver cirrhosis with moderate hepatic impairment will receive single subcutaneous (SC) injection of JNJ-73763989 on Day 1 under fasted condition.
Arm Title
Part A: Group 2
Arm Type
Experimental
Arm Description
Participants with normal liver function with no liver cirrhosis will receive single SC injection of JNJ-73763989 on Day 1 under fasted condition.
Arm Title
Part B: Group 3 (optional)
Arm Type
Experimental
Arm Description
Participants with liver cirrhosis with mild hepatic impairment will receive single SC injection of JNJ-73763989 on Day 1 under fasted condition.
Arm Title
Part B: Group 4 (optional)
Arm Type
Experimental
Arm Description
Participants with liver cirrhosis with severe hepatic impairment will receive SC injection of JNJ-73763989 on Day 1 under fasted condition.
Intervention Type
Drug
Intervention Name(s)
JNJ-73763989
Intervention Description
JNJ-73763989 will be administered SC under fasted condition.
Primary Outcome Measure Information:
Title
Plasma Concentration of JNJ-73763989
Description
Plasma concentration of oral dose of JNJ-73763989 will be reported.
Time Frame
Up to Day 4
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
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.
Time Frame
Up to 42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Sciences Ireland UC Clinical Trial
Organizational Affiliation
Janssen Sciences Ireland UC
Official's Role
Study Director
Facility Information:
Facility Name
CRS Clinical Research Services Kiel GmbH
City
Kiel
ZIP/Postal Code
24105
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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