A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults
Completed · Phase 1 · Has a placebo group
Conditions studied: RSV Infection, QTc Interval
In brief
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.
Key facts
- Study ID
- NCT06601192
- Run by
- Enanta Pharmaceuticals, Inc
- People needed
- 72
- Starts
- 2024-07-15
- Expected to finish
- 2025-02-25
- Last updated by the study team
- 2025-07-28
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- ICON — Lenexa, Kansas, United States
- ICON Early Phase, LLC — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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