A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults (NCT06601192) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults
United States72 participantsStarted 2024-07-15
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
What they're measuring
1
Time-matched, placebo-corrected change-from-baseline QTc based on the Fridericia correction QTcF (ΔΔQTcF) after TD and SD of Zelicapavir