Trial reportAntimicrobial agents and chemotherapy2011
Pharmacokinetics of solithromycin (CEM-101) after single or multiple oral doses and effects of food on single-dose bioavailability in healthy adult subjects.
Trial report in Antimicrobial agents and chemotherapy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
24 citing papers in PubMed.
- Randomized, double-blind, multicenter phase 2 study comparing the efficacy and safety of oral solithromycin (CEM-101) to those of oral levofloxacin in the treatment of patients with community-acquired bacterial pneumonia.Antimicrobial agents and chemotherapy · 2013Trial
- Exploring the repurposed role of solithromycin as an antivirulence agent againstFrontiers in microbiology · 2025Article
- Emerging Treatment Options for Infections by Multidrug-Resistant Gram-Positive Microorganisms.Microorganisms · 2020Review
- Pharmacotherapy of Lower Respiratory Tract Infections in Elderly-Focused on Antibiotics.Frontiers in pharmacology · 2019Review
- Metabolism, Excretion, and Mass Balance of Solithromycin in Humans.Antimicrobial agents and chemotherapy · 2018Article
- Development of an Adult Physiologically Based Pharmacokinetic Model of Solithromycin in Plasma and Epithelial Lining Fluid.CPT: pharmacometrics & systems pharmacology · 2017Article
- Nature nurtures the design of new semi-synthetic macrolide antibiotics.The Journal of antibiotics · 2017Review
- Spotlight on solithromycin in the treatment of community-acquired bacterial pneumonia: design, development, and potential place in therapy.Drug design, development and therapy · 2017Review
- Solithromycin: A Novel Fluoroketolide for the Treatment of Community-Acquired Bacterial Pneumonia.Drugs · 2016Review
- Efficacy of Solithromycin (CEM-101) for Experimental Otitis Media Caused by Nontypeable Haemophilus influenzae and Streptococcus pneumoniae.Antimicrobial agents and chemotherapy · 2016Article
- Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.Antimicrobial agents and chemotherapy · 2016Article
- Type III Secretion-Dependent Sensitivity of Escherichia coli O157 to Specific Ketolides.Antimicrobial agents and chemotherapy · 2016Article
- A New, Potent, and Placenta-Permeable Macrolide Antibiotic, Solithromycin, for the Prevention and Treatment of Bacterial Infections in Pregnancy.Frontiers in immunology · 2016Review
- Current and future antimicrobial treatment of gonorrhoea - the rapidly evolving Neisseria gonorrhoeae continues to challenge.BMC infectious diseases · 2015Review
- Safety and Pharmacokinetics of Solithromycin in Subjects with Hepatic Impairment.Antimicrobial agents and chemotherapy · 2015Article
- In vitro activity of the new fluoroketolide solithromycin (CEM-101) against macrolide-resistant and -susceptible Mycoplasma genitalium strains.Antimicrobial agents and chemotherapy · 2014Article
- Maternal administration of solithromycin, a new, potent, broad-spectrum fluoroketolide antibiotic, achieves fetal and intra-amniotic antimicrobial protection in a pregnant sheep model.Antimicrobial agents and chemotherapy · 2014Article
- Antimicrobial activity of solithromycin against clinical isolates of Legionella pneumophila serogroup 1.Antimicrobial agents and chemotherapy · 2014Article
- Investigational antimicrobial agents of 2013.Clinical microbiology reviews · 2013Review
- Emergence of multidrug-resistant, extensively drug-resistant and untreatable gonorrhea.Future microbiology · 2012Review
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The pharmacokinetics of orally administered solithromycin (CEM-101), a novel fluoroketolide, were evaluated in healthy subjects in three phase 1 studies. In two randomized, double-blinded, placebo-controlled studies, escalating single oral doses of solithromycin (50 to 1,600 mg) or seven oral daily doses (200 to 600 mg) of solithromycin were administered. A third study evaluated the effects of food on the bioavailability of single oral doses (400 mg) of solithromycin. Following single doses, the median time to peak concentration (Tmax) ranged from 1.5 h to 6 h. The mean maximum measured plasma concentration (Cmax) ranged from 0.0223 μg/ml to 19.647 μg/ml, and the area under the concentration-versus-time curve from time zero to time t (AUC0-t) ranged from 0.0402 μg·h/ml to 28.599 μg·h/ml. There was no effect of high-fat food on the oral bioavailability of solithromycin. In the multiple-dose study, after 7 days, the mean maximum measured plasma solithromycin concentration at steady-state (Cmax,ss) ranged from 0.248 to 1.50 μg/ml, and the area under the concentration-versus-time curve over the final dosing interval (AUCτ) ranged from 2.310 to 18.41 μg·h/ml. These values indicate a greater than proportional increase in exposure at 200 and 400 mg but a proportional exposure at 600 mg. Median Tmax values remained constant between day 1 and day 7. Moderate accumulation ratios of solithromycin were observed after 7 days of dosing. All dose regimens of solithromycin were well tolerated, and no discontinuations due to an adverse event occurred. The human pharmacokinetic profile and tolerability of solithromycin, combined with its in vitro potency and efficacy in animal models against a broad spectrum of pathogens, support further development of solithromycin.
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