A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults

Phase 1, Randomized, Double-Blind Four-Period Crossover, Thorough QT/QTc Study to Evaluate the Effects of EDP-938 on Cardiac Repolarization in Healthy Adults

The purpose of the study is to assess the effect of a therapeutic and supratherapeutic dose of zelicapavir on the corrected cardiac QT interval relative to a placebo and positive control in healthy participants.

Inclusion Criteria:

• An informed consent document signed and dated by the subject.
• Male or female individuals who are 18 to 65 years of age, inclusive
• Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
• Heterosexually active male participants and their female partners of childbearing potential must agree to use 2 effective birth control methods for the duration of the study and for 90 days after the last dose of study intervention.
• Females of childbearing potential must agree to use 2 effective birth control methods for the duration of the study and for 30 days after the last dose of study intervention.

Exclusion Criteria:

• Clinically relevant evidence or history of illness or disease
• Clinically relevant risk factors for cardiovascular abnormalities
• Pregnant or nursing females
• History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection
• Infection with HIV, HBV, HCV, or SARS CoV 2
• Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)
• Before the first dose of study intervention, participant has received any vaccine, an investigational agent or biological product within 28 days or 5 times the terminal half-life (t½), whichever is longer
• A positive urine drug screen at Screening or Day -1
• Current tobacco smokers or use of tobacco within 3 months prior to Screening
• History of regular alcohol consumption