RSV InfectionPhase 1NCT06601192
A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults
A Phase 1 study testing zelicapavir (therapeutic dose), zelicapavir (supratherapeutic dose) and moxifloxacin in people with RSV Infection and QTc Interval, run by Enanta Pharmaceuticals, Inc at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- RSV Infection, QTc Interval
- What is being tested?
- zelicapavir (therapeutic dose), zelicapavir (supratherapeutic dose) and moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2024to 25 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ICON
Lenexa, Kansas, 66219
ICON Early Phase, LLC
San Antonio, Texas, 78290
About this study
Official title: Phase 1, Randomized, Double-Blind Four-Period Crossover, Thorough QT/QTc Study to Evaluate the Effects of EDP-938 on Cardiac Repolarization in Healthy Adults
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.
- Conditions
- RSV Infection, QTc Interval
- Being tested
- zelicapavir (therapeutic dose), zelicapavir (supratherapeutic dose), Placebo, moxifloxacin
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zelicapavir (therapeutic dose)Drug
Also called EDP-938
Subjects will receive zelicapavir (TD) once per treatment period.
zelicapavir (supratherapeutic dose)Drug
Also called EDP-938
Subjects will receive zelicapavir (SD) once per treatment period.
PlaceboDrug
Subjects will receive zelicapavir matching placebo once per treatment period.
moxifloxacinDrug
Subjects will receive moxifloxin once per treatment period.
| Study group | Role | What they receive |
|---|---|---|
| zelicapavir Dose 1 (therapeutic dose) | Experimental | 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. Receives: Drug: zelicapavir (therapeutic dose) |
| zelicapavir Dose 2 (supratherapeutic dose) | Experimental | 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. Receives: Drug: zelicapavir (supratherapeutic dose) |
| placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| moxifloxacin | Experimental | 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. Receives: Drug: moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-matched, placebo-corrected change-from-baseline QTc based on the Fridericia correction QTcF (ΔΔQTcF) after TD and SD of Zelicapavir
Measured: Up to 24 hours post dose
Secondary outcomes (10)
Time-matched, placebo-corrected, change-from-baseline non-QT intervals after TD and SD of Zelicapavir
Measured: Up to 24 hours post dose
Time-matched, placebo-corrected, change-from-baseline HR after TD and SD of Zelicapavir
Measured: Up to 24 hours post dose
Concentration-QTc analysis based on the relationship between plasma concentrations of zelicapavir and ΔΔQTcF after a TD and SD of zelicapavir
Measured: Up to 96 hours post dose
Cmax of zelicapavir
Measured: Up to 96 hours post dose
Tmax of zelicapavir
Measured: Up to 96 hours post dose
t1/2 of zelicapavir
Measured: Up to 96 hours post dose
Vd/F of zelicapavir
Measured: Up to 96 hours post dose
CL/F of zelicapavir
Measured: Up to 96 hours post dose
ΔΔQTcF after moxifloxacin dosing
Measured: Up to 24 hours post dose
Safety measured by adverse events
Measured: Up to Day 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Jul 2024
- Primary completion2 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enanta Pharmaceuticals, Inc, Study director, Enanta Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601192
- Sponsor's protocol ID
- EDP 938-008
- Status last verified
- Jul 2025
- First submitted
- 27 Aug 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Randomized, Double-Blind Four-Period Crossover, Thorough QT/QTc Study to Evaluate the Effects of EDP-938 on Cardiac Repolarization in Healthy Adults
- ClinicalTrials.gov ID
- NCT06601192
- Acronym / sponsor ID
- EDP 938-008
- Conditions
- RSV Infection, QTc Interval
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| zelicapavir Dose 1 (therapeutic dose) | Experimental | Drug: zelicapavir (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 Dose 2 (supratherapeutic dose) | Experimental | Drug: zelicapavir (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. |
| placebo | Placebo comparator | Drug: PlaceboAll 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 | Experimental | Drug: moxifloxacinAll participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zelicapavir (therapeutic dose)Also: EDP-938Subjects will receive zelicapavir (TD) once per treatment period. | Drug | zelicapavir Dose 1 (therapeutic dose) |
| zelicapavir (supratherapeutic dose)Also: EDP-938Subjects will receive zelicapavir (SD) once per treatment period. | Drug | zelicapavir Dose 2 (supratherapeutic dose) |
| PlaceboSubjects will receive zelicapavir matching placebo once per treatment period. | Drug | placebo |
| moxifloxacinSubjects will receive moxifloxin once per treatment period. | Drug | moxifloxacin |
Primary outcome
Time-matched, placebo-corrected change-from-baseline QTc based on the Fridericia correction QTcF (ΔΔQTcF) after TD and SD of Zelicapavir
Time frame: Up to 24 hours post dose
10 secondary outcomes
Time-matched, placebo-corrected, change-from-baseline non-QT intervals after TD and SD of Zelicapavir
Time frame: Up to 24 hours post dose
Time-matched, placebo-corrected, change-from-baseline HR after TD and SD of Zelicapavir
Time frame: Up to 24 hours post dose
Concentration-QTc analysis based on the relationship between plasma concentrations of zelicapavir and ΔΔQTcF after a TD and SD of zelicapavir
Time frame: Up to 96 hours post dose
Cmax of zelicapavir
Time frame: Up to 96 hours post dose
Tmax of zelicapavir
Time frame: Up to 96 hours post dose
t1/2 of zelicapavir
Time frame: Up to 96 hours post dose
Vd/F of zelicapavir
Time frame: Up to 96 hours post dose
CL/F of zelicapavir
Time frame: Up to 96 hours post dose
ΔΔQTcF after moxifloxacin dosing
Time frame: Up to 24 hours post dose
Safety measured by adverse events
Time frame: Up to Day 33
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enanta Pharmaceuticals, Inc study director
Enanta Pharmaceuticals, Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing zelicapavir (therapeutic dose), zelicapavir (supratherapeutic dose) and moxifloxacin in people with RSV Infection and QTc Interval, run by Enanta Pharmaceuticals, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-matched, placebo-corrected change-from-baseline QTc based on the Fridericia correction QTcF (ΔΔQTcF) after TD and SD of Zelicapavir (time frame: Up to 24 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.