A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults
NCT ID: NCT06601192
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2024-07-15
2025-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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zelicapavir Dose 1 (therapeutic dose)
All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25.
zelicapavir (therapeutic dose)
Subjects will receive zelicapavir (TD) once per treatment period.
zelicapavir Dose 2 (supratherapeutic dose)
All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25.
zelicapavir (supratherapeutic dose)
Subjects will receive zelicapavir (SD) once per treatment period.
placebo
All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25.
Placebo
Subjects will receive zelicapavir matching placebo once per treatment period.
moxifloxacin
All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25.
moxifloxacin
Subjects will receive moxifloxin once per treatment period.
Interventions
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zelicapavir (therapeutic dose)
Subjects will receive zelicapavir (TD) once per treatment period.
zelicapavir (supratherapeutic dose)
Subjects will receive zelicapavir (SD) once per treatment period.
Placebo
Subjects will receive zelicapavir matching placebo once per treatment period.
moxifloxacin
Subjects will receive moxifloxin once per treatment period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
Yes
Sponsors
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Enanta Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Enanta Pharmaceuticals, Inc
Role: STUDY_DIRECTOR
Enanta Pharmaceuticals, Inc
Locations
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ICON
Lenexa, Kansas, United States
ICON Early Phase, LLC
San Antonio, Texas, United States
Countries
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Other Identifiers
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EDP 938-008
Identifier Type: -
Identifier Source: org_study_id
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