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

Launched by ENANTA PHARMACEUTICALS, INC · Sep 13, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a medication called zelicapavir (EDP-938) on heart activity in healthy adults. Specifically, the study aims to see how different doses of this drug affect the QTc interval, which is a measurement that helps doctors understand how well the heart is functioning. Participants will receive either the medication or a placebo (a harmless substance with no active ingredients) to compare the results.

To be eligible for the trial, individuals must be between 18 and 65 years old, have a body mass index (BMI) between 18 and 30, and agree to use effective birth control methods if they are sexually active. Those with certain health issues, a history of heart problems, or who are pregnant or nursing cannot participate. If you join the study, you will receive treatment and be monitored for your heart's activity, helping researchers learn more about how this medication works. This study is currently recruiting participants, so if you are interested, there may be opportunities to get involved.

Gender

ALL

Eligibility criteria

• 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