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Effect of Food on the Bioavailability of Omadacycline in Healthy Participants.
- Source :
- Journal of Clinical Pharmacology; Mar2017, Vol. 57 Issue 3, p321-327, 7p
- Publication Year :
- 2017
-
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<subscript>0-∞</subscript>, AUC<subscript>0-t</subscript>, and AUC<subscript>0-24</subscript> were 10.2, 7.2, and 7.2 μg·h/mL, respectively, and C<subscript>max</subscript> was 0.6 μg/mL. Compared with a fasted dose, bioavailability was reduced by 15% to 17% by a nondairy meal 4 hours before dosing, 40% to 42% by a nondairy meal 2 hours before dosing, and 59% to 63% for a dairy meal 2 hours before dosing. Two participants experienced adverse events (mild nausea, mild somnolence). A 300-mg oral dose of omadacycline administered within 2 to 4 hours after food had reduced bioavailability compared with the fasted state. Oral omadacycline should be administered in a fasted state. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00912700
- Volume :
- 57
- Issue :
- 3
- Database :
- Complementary Index
- Journal :
- Journal of Clinical Pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 121268841
- Full Text :
- https://doi.org/10.1002/jcph.814