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

NCT ID: NCT04208386

Last Updated: 2020-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-08
• Study Completion Date: 2020-07-20

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.

Conditions

Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

JNJ-73763989

Intervention Type: DRUG

JNJ-73763989 will be administered SC under fasted condition.

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.

Group Type: EXPERIMENTAL

JNJ-73763989

Intervention Type: DRUG

JNJ-73763989 will be administered SC under fasted condition.

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.

Group Type: EXPERIMENTAL

JNJ-73763989

Intervention Type: DRUG

JNJ-73763989 will be administered SC under fasted condition.

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.

Group Type: EXPERIMENTAL

JNJ-73763989

Intervention Type: DRUG

JNJ-73763989 will be administered SC under fasted condition.

Interventions

JNJ-73763989

JNJ-73763989 will be administered SC under fasted condition.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Sciences Ireland UC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Sciences Ireland UC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Sciences Ireland UC

Locations

CRS Clinical Research Services Kiel GmbH

Kiel, , Germany

Countries

Germany

References

Kakuda TN, Halabi A, Klein G, Sanga M, Guinard-Azadian C, Kowalik M, Nedoschinsky K, Nangosyah J, Ediage EN, Hillewaert V, Verboven P, Goris I, Snoeys J, Palmer M, Biermer M. Pharmacokinetics of JNJ-73763989 and JNJ-56136379 (Bersacapavir) in Participants With Moderate Hepatic Impairment. J Clin Pharmacol. 2023 Jun;63(6):732-741. doi: 10.1002/jcph.2214. Epub 2023 Mar 20.

Reference Type: DERIVED

PMID: 36786053 (View on PubMed)

Other Identifiers

73763989HPB1002

Identifier Type: OTHER

Identifier Source: secondary_id

2019-003083-51

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108708

Identifier Type: -

Identifier Source: org_study_id