scholarly journals A Phase I, Open-Label, Parallel-Group, Single-Dose Trial of the Pharmacokinetics, Safety, and Tolerability of Cannabidiol in Subjects with Mild to Severe Renal Impairment

2019 ◽  
Vol 59 (6) ◽  
pp. 747-755 ◽  
Author(s):  
Bola Tayo ◽  
Lesley Taylor ◽  
Farhad Sahebkar ◽  
Gilmour Morrison
Keyword(s):  
Single Dose ◽  
Renal Impairment ◽  
Phase I ◽  
Severe Renal Impairment ◽  
Open Label ◽  
Parallel Group ◽  
Dose Trial

Pharmacokinetics of fingolimod and metabolites in subjects with severe renal impairment: An open-label, single-dose, parallel-group study

2015 ◽  
Vol 53 (10) ◽  
pp. 847-854 ◽  
Author(s):  
Olivier J. David ◽  
Maxwell Pryce ◽  
Karin Meiser ◽  
Franck Picard ◽  
Corinne Emotte ◽  
...  
Keyword(s):  
Single Dose ◽  
Renal Impairment ◽  
Severe Renal Impairment ◽  
Open Label ◽  
Parallel Group Study ◽  
Parallel Group

scholarly journals Effect of renal impairment on the pharmacokinetics of prucalopride: a single- dose open-label Phase I study

2012 ◽  
pp. 407
Author(s):  
Lieve Vandeplassche ◽  
Smith ◽  
Mannaert ◽  
Verhaeghe ◽  
Kerstens ◽  
...  
Keyword(s):  
Single Dose ◽  
Renal Impairment ◽  
Phase I ◽  
Phase I Study ◽  
Open Label ◽  
Open Label Phase

scholarly journals The Influence of Hepatic and Renal Impairment on the Pharmacokinetics of a Treatment for Herpes Zoster, Amenamevir (ASP2151): Phase 1, Open-Label, Single-Dose, Parallel-Group Studies

2017 ◽  
Vol 34 (12) ◽  
pp. 2612-2624 ◽  
Author(s):  
Tomohiro Kusawake ◽  
Donna Kowalski ◽  
Akitsugu Takada ◽  
Kota Kato ◽  
Masataka Katashima ◽  
...  
Keyword(s):  
Single Dose ◽  
Herpes Zoster ◽  
Renal Impairment ◽  
Phase 1 ◽  
Open Label ◽  
Parallel Group

scholarly journals 1318. Pharmacokinetics and Safety of Cefepime-Taniborbactam (formerly Cefepime/VNRX-5133) in Subjects with Renal Impairment

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S670-S670
Author(s):  
Brooke Geibel ◽  
James A Dowell ◽  
Thomas C Marbury ◽  
William Smith ◽  
Paul C McGovern ◽  
...  
Keyword(s):  
Single Dose ◽  
Adverse Events ◽  
Renal Impairment ◽  
Clinical Laboratory ◽  
Severe Renal Impairment ◽  
Phase 1 ◽  
Vital Signs ◽  
Open Label ◽  
Independent Contractor ◽  
Serious Adverse Events

Abstract Background Taniborbactam is a novel, non-ß-lactam, ß-lactamase inhibitor with activity against serine (Class A, C, D) and metallo (Class B) ß-lactamases including epidemiologically important carbapenemases. Both cefepime and taniborbactam are predominantly renally excreted and are likely to require dose adjustment in patients with renal impairment and end-stage renal disease (ESRD). The current study was designed to evaluate the pharmacokinetics and safety in patients with renal impairment and ESRD. Methods This was a Phase 1, open-label study in subjects with normal renal function (eCLCR ≥ 90 mL/min) matched to subjects with mild, moderate, and severe renal impairment (eGFR 60-89, 30-59, and < 30 mL/min/1.73m2, respectively), and patients with ESRD on hemodialysis. Subjects received a single dose of cefepime 2 g and taniborbactam 500 mg; subjects with ESRD received a single dose before HD and after a 9 day washout period, following HD. PK parameters including AUC0-inf and total body clearance (CL) were evaluated. Safety assessments included adverse events (AEs), vital signs, clinical laboratory evaluations, electrocardiograms, and physical examinations. Results Thirty-three subjects were enrolled; 67% male, 58% white and 39% black/African Americans. Median age and BMI were 55.0 years and 29.5 kg/m2, respectively. For both cefepime and taniborbactam, exposures increased, and CL decreased with increasing renal impairment (see Table). The hemodialysis extraction ratio was 49.7% and 47.4% for taniborbactam and cefepime respectively. No safety signals were observed and there were no serious adverse events. Table Conclusion Cefepime and taniborbactam CL is similarly reduced with varying degrees of renal impairment. Dialysis removes a high fraction of both drugs. Dose adjustments recommended for cefepime are appropriate for taniborbactam. Disclosures Brooke Geibel, BS, Venatorx Pharmaceuticals (Employee, Shareholder) James A. Dowell, PhD, Venatorx Pharmaceuticals (Independent Contractor) Thomas C. Marbury, MD, Venatorx Pharmaceuticals (Independent Contractor) William Smith, MD, Venatorx Pharmaceuticals (Independent Contractor) Paul C. McGovern, MD, Venatorx Pharmaceuticals (Employee) Cynthia Richards, MD, Venatorx Pharmaceuticals (Independent Contractor) Tim Henkel, MD, PhD, Venatorx Pharmaceuticals (Employee, Shareholder)

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