Trial reportJournal of clinical pharmacology2017
Effect of Food on the Bioavailability of Omadacycline in Healthy Participants.
Trial report in Journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of omadacycline for treating complicated skin and soft tissue infections: a meta-analysis of randomized controlled trials.BMC infectious diseases · 2024Pooled it
- Safety and Pharmacokinetics of the Aminomethylcycline Antibiotic Omadacycline Administered to Healthy Subjects in Oral Multiple-Dose Regimens.Antimicrobial agents and chemotherapy · 2018Trial
- Next-generation hybrid bioanalytical platforms and clinical integration of TDM technologies for precision monitoring to optimize last-resort antibiotic therapy.Frontiers in pharmacology · 2026Review
- Omadacycline Pharmacokinetics: Characteristics, Contributing Factors, and Clinical Significance.Drugs in R&D · 2025Review
- LC-MS/MS quantification of omadacycline in human plasma for therapeutic drug monitoring: method development and clinical application.Scientific reports · 2025Article
- Pharmacotherapeutic Considerations in the Treatment of Nontuberculous Mycobacterial Infections: A Primer for Clinicians.Open forum infectious diseases · 2024Review
- New Antimicrobials for Gram-Positive Sustained Infections: A Comprehensive Guide for Clinicians.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Bidirectional Interaction between Tetracyclines and Gut Microbiome.Antibiotics (Basel, Switzerland) · 2023Review
- Contemporary Pharmacotherapies for Nontuberculosis Mycobacterial Infections: A Narrative Review.Infectious diseases and therapy · 2023Review
- Omadacycline for management of Mycobacterium abscessus infections: a review of its effectiveness, place in therapy, and considerations for use.BMC infectious diseases · 2022Review
- Pharmacokinetics, Safety and Pharmacokinetics/Pharmacodynamics Analysis of Omadacycline in Chinese Healthy Subjects.Frontiers in pharmacology · 2022Article
- Use of oral tetracyclines in the treatment of adult outpatients with skin and skin structure infections: Focus on doxycycline, minocycline, and omadacycline.Pharmacotherapy · 2021Review
- Use of Oral Tetracyclines in the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia: A Literature Review on the Often-Overlooked Antibiotic Class.Antibiotics (Basel, Switzerland) · 2020Review
- Nonclinical Pharmacokinetics, Protein Binding, and Elimination of KBP-7072, an Aminomethylcycline Antibiotic, in Animal Models.Antimicrobial agents and chemotherapy · 2020Article
- Omadacycline: A Review of the Clinical Pharmacokinetics and Pharmacodynamics.Clinical pharmacokinetics · 2020Review
- Review
- Omadacycline: A Modernized Tetracycline.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Article
- Pharmacokinetics and Pharmacodynamics of Oral and Intravenous Omadacycline.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Review
- Omadacycline.Hospital pharmacy · 2019Review
- Omadacycline: a novel aminomethylcycline.Infection and drug resistance · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Omadacycline is a first-in-class aminomethylcycline antibiotic being evaluated in phase 3 studies as oral and intravenous monotherapy for bacterial infections. This was a phase 1, randomized, open-label, 4-period, crossover study that evaluated the effect of food consumption on the bioavailability of omadacycline. Healthy participant were randomized to 1 of 4 sequences, which included the following predose conditions in different orders (A) ≥6-hour fast, (B) high-fat, nondairy meal 4 hours before dosing, (C) high-fat, nondairy meal 2 hours before dosing, and (D) high-fat meal containing dairy 2 hours before dosing. Participants received a single 300-mg oral dose of omadacycline during each treatment period; periods were separated by ≥5 days. Blood samples for pharmacokinetic (PK) analysis were collected over 24 hours after each dose, and safety assessments were performed during each treatment period. Least-squares mean and 90% confidence intervals were compared for fed state vs fasted state. Thirty-one participants were included in the PK analysis. Fasted AUC
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.