A Study to Evaluate the Effect of Renal Impairment on JNJ-56136379 in Adult Participants

NCT04474210 | Terminated Phase 1 FDA Drug

• 2 other identifiers: CR10880256136379HPB1010
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of JNJ-56136379 in adult participants with renal impairment compared with healthy participants with normal renal function.

Conditions

Renal Insufficiency

Keywords

Renal Impairment

Outcome Measures

Primary Outcomes (12)

• Maximum Observed Plasma Analyte Concentration (Cmax)

  Cmax is defined as the maximum observed plasma analyte concentration.

  Up to Day 29

• Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax)

  Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration.

  Up to Day 29

• Area Under the Analyte Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24])

  AUC (0-24) is defined as area under the analyte concentration-time curve (AUC) from time 0 to 24 hours postdose, calculated by linear-linear trapezoidal summation.

  Up to 24 hours postdose

• Area Under the Analyte Concentration-time Curve From Time Zero to 144 Hours Postdose (AUC [0-144])

  AUC (0-144) is defined as AUC from time 0 to 144 hours postdose, calculated by linear-linear trapezoidal summation.

  Up to 144 hours postdose

• Area Under the Analyte Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last])

  AUC (0-last) is defined as AUC from time 0 to the time of the last measurable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation.

  Up to Day 29

• Area Under the Analyte Concentration-time Curve From Time Zero to Infinity (AUC [0-infinity])

  AUC (0-infinity) is defined as AUC from time 0 to infinity, calculated as the sum of AUC (0-last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-BQL) concentration; and lambda(z) is apparent terminal elimination rate constant.

  Up to Day 29

• Total Apparent Oral Clearance (CL/F)

  CL/F is defined as total apparent oral clearance, calculated as dose/AUC (0-infinity).

  Up to Day 29

• Apparent Volume of Distribution (Vd/F)

  Vd/F is defined as apparent volume of distribution, calculated as dose/\[lambda (z)\*AUC (0-infinity)\].

  Up to Day 29

• Apparent Terminal Elimination Rate Constant (Lambda[z])

  Lambda(z) is defined as apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log-transformed concentration vs time curve.

  Up to Day 29

• Apparent Terminal Elimination Half-life (t1/2)

  t1/2 is defined as apparent terminal elimination half-life, calculated as 0.693/lambda(z).

  Up to Day 29

• Percentage of JNJ-56136379 Excreted in Urine (Ae,%Dose)

  Ae,%Dose is defined as cumulative urinary recovery represented as a percentage of dose, calculated as 100\*(Aetotal/Dose).

  Up to Day 7

• Renal Clearance (CLr)

  CLr is defined as renal clearance, calculated as Ae(0-144h)/AUC(144h).

  Up to 144 hours postdose

Secondary Outcomes (1)

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

  Up to 8 weeks

Study Arms (5)

Part A: Group 1

EXPERIMENTAL

Participants with severe renal impairment and/or kidney failure (estimated glomerular filtration rate \[eGFR\] less than \[\<\] 30 milliliter\[mL\]/minute but not yet on hemodialysis) will receive a single oral dose of JNJ-56136379.

Drug: JNJ-56136379

Part A: Group 2

ACTIVE COMPARATOR

Healthy participants with normal renal function (eGFR greater than or equal to \[\>=\] 90 mL/minute), will receive a single oral dose of JNJ-56136379.

Drug: JNJ-56136379

Part B: Group 3 (Optional)

EXPERIMENTAL

Participants with mild renal impairment (eGFR: 60 to 89 mL/minute) will receive a single oral dose of JNJ-56136379.

Drug: JNJ-56136379

Part B: Group 4 (Optional)

EXPERIMENTAL

Participants with moderate renal impairment (eGFR: 30 to 59 mL/minute) will receive a single oral dose of JNJ-56136379.

Drug: JNJ-56136379

Part B: Group 5 (Optional)

EXPERIMENTAL

Participants with kidney failure (eGFR: \<15 mL/minute and on hemodialysis; pharmacokinetic \[PK\] to be evaluated during non-dialysis days) will receive a single oral dose of JNJ-56136379.

Drug: JNJ-56136379

Interventions

JNJ-56136379 DRUG

Participants will receive JNJ-56136379 tablets orally.

Part A: Group 1; Part A: Group 2; Part B: Group 3 (Optional); Part B: Group 4 (Optional); Part B: Group 5 (Optional)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Body mass index (BMI) (kilograms \[kg\]/height \[m\]\^2) between 18.0 and 38.0 kilogram/meter\^2 (kg/m2) (inclusive), and body weight not less than (\<) 50 kg
• Participants with normal renal function:
• Have normal renal function defined as estimated glomerular filtration rate (eGFR) greater than or equal to (\>=) 90 milliliter/minute computed with the online calculator on the CKD-EPI website by use of the Chronic Kidney Disease Epidemiology Collaboration creatinine clearance (CKD-EPIcr) result
• Must have stable renal function as defined as: (a) for participants with impaired renal function: \<20 percent (%) change in serum creatinine concentrations between screening and Day -1; (b) for healthy participants: a change in serum creatinine concentration \<0.2 milligram per deciliter (mg/dL) between screening and Day -1
• Participants with renal impairment:
• Have an impaired renal function based on eGFR as(eGFR computed with the online calculator on the CKD-EPI website providing eGFR (in mL/min units) by use of the CKD-EPIcr result: (a) eGFR \<90 to 60 mL/minute for participants in Group 3 (mild renal impairment cohort); (b) eGFR 30 to 59 mL/minute for participants in Group 4 (moderate renal impairment cohort); (c) eGFR \<30 mL/minute but not yet on hemodialysis, for participants in Group 1 (severe renal impairment and/or kidney failure); (d) eGFR \<15 mL/minute and on hemodialysis, for participants in Group 5 (kidney failure)
• Concomitant medications to treat underlying disease states or medical conditions related to renal impairment are allowed. Participants must be on a stable dose of medication and/or treatment regimen for at least 2 months (3 months for thyroid hormone replacement therapy \[HRT\]) before dosing as well as during the study

You may not qualify if:

• \- Individuals who take creatine supplements, have a non-standard muscle mass such as amputation, malnutrition, or muscle wasting; because these factors are not accounted for in the prediction equations for GFR chronic kidney disease epidemiology collaboration (CKD EPI)
• Participants with normal renal function:
• Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or Day -1, as deemed appropriate by the investigator
• Clinically significant abnormal physical examination, vital signs, body temperature, or 12 lead ECG at screening or Day -1, as deemed appropriate by the investigator
• Participants with renal impairment:
• Evidence of clinically apparent concurrent disease based upon complete clinical laboratory testing, full physical examination, or medical history, except for controlled hypertension and those problems directly associated with the primary diagnosis of renal impairment
• Any clinically significant laboratory abnormality except abnormalities that may be caused by renal impairment

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

The Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

JNJ-56136379

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 16, 2020
• Study Start: August 19, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

US (2)