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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Enrollment
200
Oral suspension of Zoliflodacin 3g
Oral suspension of matching placebo
Parexel EPCU
Berlin, Germany
Parexel EPCU
London, United Kingdom
Sperm concentration
Percentage of participants with a ≥50% decrease from baseline in sperm concentration (million/mL) at Week 13
Time frame: Week 13 (and potentially week 26)
Semen Volume
Change in semen volume (in mL)
Time frame: At baseline and week 13
Sperm count
Total sperm count per ejaculate (million)
Time frame: At Baseline and week 13
Progressive mobility
Sperm exhibiting active forward movement (μm/s)
Time frame: At Baseline and Week 13
Morphology
Evaluated using Tygerberg Strict Criteria (%)
Time frame: At baseline and week 13
Serum Hormones (LH)
Change in luteinizing hormone (LH), shift analysis relative to reference ranges
Time frame: At Baseline and Week 13
Serum hormones (FSH)
Change in Follicle Stimulating Hormone (FSH), shift analysis relative to reference ranges
Time frame: At Baseline and Week 13
Serum Hormones (Testosterone)
Change in Testosterone, shift analysis relative to reference ranges
Time frame: At baseline and week 13
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