Clinical Research Directory

Study to Evaluate the Effect of Zoliflodacin on Testicular Function in Healthy Adult Men

This study is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of zoliflodacin on testicular function in healthy adult men. Participants will be screened within 21 days before randomization (Day 1), including collection of 2 semen samples (each collected after a ≥48 hours and ≤7 days ejaculation-free period). Approximately 220 participants who provide written informed consent and meet all inclusion and no exclusion criteria will be enrolled and randomized in a 1:1 fashion to receive a single dose of either zoliflodacin 3 g or placebo administered as an oral suspension on Day 1. Each participant will be contacted by telephone at Week 1 and at Week 7 post dosing to review adverse events (AEs), concomitant medications and procedures, and genitourinary symptoms. Each participant will return to the trial site at Week 13 for collection of 2 semen samples (each collected after a ≥48 hours and ≤7 days ejaculation-free period). A serum sample will also be collected for hormone testing (luteinizing hormone \[LH\], follicle-stimulating hormone \[FSH\], and total testosterone) at Week 13 to support biological interpretation of any decrease in sperm concentration. Participants who do not have a ≥50% decrease from baseline in sperm concentration at Week 13 will complete the trial at Week 13 (end of trial). Participants with a ≥50% decrease from baseline in sperm concentration at Week 13 will return to the trial site at Week 26 for collection of 2 semen samples (independent ejaculates, each collected after a ≥48 hours and ≤7 days ejaculation-free period) for evaluation of the reversibility of the Week 13 finding, following completion of a one additional spermatogenic cycle post completion of dosing/drug exposure (FDA 2018) (end of trial). All Adverse Events, medications, and procedures will be recorded from the signing of the informed consent form (ICF) through the end-of-trial visit (Week 13, Week 26, or Early Termination)