Status:
COMPLETED
A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults
Lead Sponsor:
Enanta Pharmaceuticals, Inc
Conditions:
RSV Infection
QTc Interval
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06601192
Start Date
July 15 2024
End Date
February 25 2025
Last Update
July 28 2025
Active Locations (2)
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1
ICON
Lenexa, Kansas, United States, 66219
2
ICON Early Phase, LLC
San Antonio, Texas, United States, 78290