Pharmacokinetics and safety of TBAJ-587, a novel antimycobacterial diarylquinoline, in healthy participants.
Jerry Nedelman, Almari Conradie, Antonio Lombardi et al.
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In 30 seconds
This Phase I randomized controlled trial evaluated the pharmacokinetics and safety of TBAJ-587, a novel antimycobacterial agent, in 92 healthy adults. The study found that TBAJ-587 exhibited linear plasma exposure for AUC tau and a 3.46-fold increase in C max after a high-fat meal. The drug was generally safe and well tolerated.
Key findings
- TBAJ-587 showed a 3.46-fold increase in mean C max after a high-fat meal.
- Mean accumulation ratios for C max ranged from 1.69 to 2.32 across doses.
- No deaths or serious adverse events were reported during the trial.
- Mean terminal half-lives of TBAJ-587 ranged from approximately 80 to 111 days.
Why it matters
Understanding the pharmacokinetics and safety profile of TBAJ-587 is crucial for clinicians considering new treatment options for tuberculosis, especially in the context of drug-resistant strains.