Study S003228

A Single-dose, Open-label, Parallel-group Study to Evaluate JNJ-64565111 Pharmacokinetics and Safety in Adult Subjects With Varying Degrees of Renal Function

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT03546205
Study type: INTERVENTIONAL
Allocation: NON_RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 40
Start: 2018-06-06
Primary completion: 2018-12-17
Lead sponsor: Janssen Research & Development, LLC
Conditions: Kidney Failure, Chronic
Interventions: DRUG:JNJ-64565111
Results posted: FALSE
Secondary identifiers: OTHER:64565111OBE1003

Registered primary outcomes

Maximum Observed Serum Analyte Concentration (Cmax) 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 [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 [Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose]

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