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A Study to Evaluate the Effect of Hepatic Impairment on JNJ-56136379

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208399
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Sciences Ireland UC

Brief Summary:
The purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of JNJ-56136379 in participants with liver cirrhosis and 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-56136379 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of JNJ-56136379
Actual Study Start Date : January 9, 2020
Estimated Primary Completion Date : December 17, 2020
Estimated Study Completion Date : December 17, 2020

Arm Intervention/treatment
Experimental: Part A: Group 1
Participants with liver cirrhosis with moderate hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition.
Drug: JNJ-56136379
JNJ-56136379 will be administered orally in fed condition.

Experimental: Part A: Group 2
Participants with normal liver function with no liver cirrhosis will receive a single oral dose of JNJ-56136379 in fed condition.
Drug: JNJ-56136379
JNJ-56136379 will be administered orally in fed condition.

Experimental: Part B: Group 3 (optional)
Participants with liver cirrhosis with mild hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition.
Drug: JNJ-56136379
JNJ-56136379 will be administered orally in fed condition.

Experimental: Part B: Group 4 (optional)
Participants with liver cirrhosis with severe hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition.
Drug: JNJ-56136379
JNJ-56136379 will be administered orally in fed condition.




Primary Outcome Measures :
  1. Plasma Concentration of JNJ-56136379 [ Time Frame: Up to Day 21 ]
    Plasma concentration of oral dose of JNJ-56136379 will be assessed.


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 6 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • For all participants: Body mass index (BMI) between 18.0 and 38 kilogram per meter square (kg/m2), extremes included; 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 kilogram [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 and with concurrent stable medical conditions if the condition(s) will not introduce an additional risk factor and will not interfere with the study objectives.
  • 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-6379 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 hepatitis C virus [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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208399


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Germany
APEX GmbH Recruiting
Munchen, Germany, 81241
Sponsors and Collaborators
Janssen Sciences Ireland UC
Investigators
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Study Director: Janssen Sciences Ireland UC Clinical Trials Janssen Sciences Ireland UC
Additional Information:
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Responsible Party: Janssen Sciences Ireland UC
ClinicalTrials.gov Identifier: NCT04208399    
Other Study ID Numbers: CR108713
2019-003071-20 ( EudraCT Number )
56136379HPB1009 ( Other Identifier: Janssen Sciences Ireland UC )
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
URL: https://www.janssen.com/clinical-trials/transparency

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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:
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Liver Diseases
Digestive System Diseases