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Clinical Trial Details

Trial ID: L0702
Source ID: NCT03546205
Associated Drug: Jnj-64565111
Title: A Study to Evaluate JNJ-64565111 Pharmacokinetics and Safety in Adult Participants With Varying Degrees of Renal Function
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Kidney Failure, Chronic
Interventions: DRUG: JNJ-64565111
Outcome Measures: Primary: Maximum Observed Serum Analyte Concentration (Cmax) of JNJ-64565111, Cmax is the maximum observed serum analyte concentration of JNJ-64565111., Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose|Area Under the Serum Analyte Concentration-Time Curve from Time Zero to Last Measurable (not Below Quantification Limit) Concentration (AUC[0-last]) of JNJ-64565111, AUC \[0-Last\] is the area under the serum analyte concentration versus time curve from time zero to the time of the last measurable (not below quantification limit) concentration of JNJ-64565111, calculated by linear-linear trapezoidal summation., Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose|Area Under the Serum Analyte Concentration-Time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-64565111, AUC (0-infinity) is the area under the serum analyte concentration-time curve from time zero to infinite time, calculated as AUC(last) + C(last)/lamda(z) where C(last) is the last observed measurable (not below quantification limit) concentration of JNJ-64565111., Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose | Secondary: Number of Participants with Antibodies to JNJ-64565111, Number of participants with antibodies to JNJ-64565111 will be reported., Predose, Days 7, 29 and 42|Number of Participants with Adverse Events, An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily have a causal relationship with the relevant investigational product., Approximately 9 weeks
Sponsor/Collaborators: Sponsor: Janssen Research & Development, LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2018-06-06
Completion Date: 2018-12-17
Results First Posted:
Last Update Posted: 2025-04-01
Locations: Orlando Clinical Research Center, Orlando, Florida, 32809, United States|AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company, Knoxville, Tennessee, 37923, United States
URL: https://clinicaltrials.gov/show/NCT03546205