Randomized, Open-Label Study of the Pharmacokinetics and Safety of Oral and Intravenous Administration of Omadacycline to Healthy Subjects

@article{Sun2016RandomizedOS,
  title={Randomized, Open-Label Study of the Pharmacokinetics and Safety of Oral and Intravenous Administration of Omadacycline to Healthy Subjects},
  author={Haiying Sun and Lillian S. L. Ting and Surendra Machineni and Jens Praestgaard and Andreas Kuemmell and Daniel S. Stein and Gangadhar Sunkara and Steven J. Kovacs and Stephen A. Villano and S. Ken Tanaka},
  journal={Antimicrobial Agents and Chemotherapy},
  year={2016},
  volume={60},
  pages={7431 - 7435}
}
ABSTRACT Omadacycline is a first-in-class aminomethylcycline antibiotic with microbiological activity against Gram-positive and Gram-negative aerobes and anaerobes and atypical bacteria that is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The bioavailability of a phase 3 tablet formulation relative to that obtained via intravenous (i.v.) administration (and of other oral formulations relative… Expand
Safety and Pharmacokinetics of the Aminomethylcycline Antibiotic Omadacycline Administered to Healthy Subjects in Oral Multiple-Dose Regimens
TLDR
All doses were generally well tolerated, but the 600-mg dose was associated with more gastrointestinal adverse events than the other doses, and the kinetics of omadacycline plasma accumulation were similar between dose levels. Expand
Pharmacokinetics and Pharmacodynamics of Oral and Intravenous Omadacycline
  • K. Rodvold, M. Pai
  • Medicine
  • Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
  • 2019
TLDR
Omadacycline formulations approved in the United States for treating acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia in adults support once-daily dosing, and fAUC0–24/MIC ratio is identified as the parameter that correlates with in vivo efficacy. Expand
Pharmacokinetics and Safety of Omadacycline in Subjects with Impaired Renal Function
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This study demonstrates that no dose adjustment is necessary for omadacycline in patients with impaired renal function or on days when patients are receiving hemodialysis, and generally safe and well tolerated in both ESRD and healthy subjects. Expand
The Effect of Verapamil, a P-gp Inhibitor, on the Pharmacokinetics, Safety, and Tolerability of Omadacycline in Healthy Adults: A Phase I, Open-Label, Single-Sequence Study
TLDR
Findings suggest that, if given with a known P-gp inhibitor, dose adjustment of oral omadacycline is not warranted based on small increases in absorption and systemic exposure. Expand
Omadacycline: A Review of the Clinical Pharmacokinetics and Pharmacodynamics
TLDR
A population pharmacokinetic model was developed with data from healthy subjects and infected patients and used to establish interpretive criteria for in vitro susceptibility testing and dosing regimens of omadacycline for treating acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Expand
An Open-Label Study of the Impact of Hepatic Impairment on the Pharmacokinetics and Safety of Single Oral and Intravenous Doses of Omadacycline
TLDR
It is suggested that no omadacycline dose adjustment is warranted in patients with hepatic impairment and healthy subjects following i.v. or oral administration, and asymptomatic increases in heart rate were observed; none was considered an AE. Expand
Pharmacokinetics, Safety, and Clinical Outcomes of Omadacycline in Women with Cystitis: Results from a Phase 1b Study
TLDR
Preliminary results indicate that omadacycline warrants further evaluation in larger controlled UTI studies, as it appears to be safe and well tolerated. Expand
Randomized, Double-Blind, Placebo- and Positive-Controlled Crossover Study of the Effects of Omadacycline on QT/QTc Intervals in Healthy Subjects
TLDR
Omadacycline had no effect on cardiac conduction (PR and QRS intervals) but caused an increase in heart rate and the possibility of an effect on placebo-corrected ΔQTcS exceeding 10 ms can be excluded at omadacyCline concentrations in plasma of up to ∼8 μg/ml. Expand
Omadacycline: A Novel Oral and Intravenous Aminomethylcycline Antibiotic Agent
TLDR
Omadacycline possesses broad-spectrum antibacterial activity against Gram-positive and Gram-negative aerobic, anaerobic, and atypical bacteria, and remains active against bacterial isolates possessing common tetracyCline resistance mechanisms such as efflux pumps and ribosomal protection proteins. Expand
Omadacycline: A New Tetracycline Antibiotic
TLDR
Omadacycline provides clinicians with an additional parenteral and oral option for the treatment of adults with ABSSSI and CABP, and is well tolerated, with nausea being a common adverse effect, but is associated with food and drug interactions. Expand
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