A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults

Phase 1

Recruiting

• Conditions: RSV Infection; QTc Interval
• Interventions: Drug: zelicapavir (therapeutic dose); Drug: zelicapavir (supratherapeutic dose); Drug: Placebo; Drug: moxifloxacin

• Registration Number: NCT06601192
• Lead Sponsor: Enanta Pharmaceuticals, Inc

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 participants.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-15
• Study First Submitted: 2024-08-27
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-24
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
zelicapavir Dose 1 (therapeutic dose)	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)	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	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	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.

Primary Outcome Measures

Name	Time	Method
Time-matched, placebo-corrected change-from-baseline QTc based on the Fridericia correction QTcF (ΔΔQTcF) after TD and SD of Zelicapavir	Up to 24 hours post dose

Secondary Outcome Measures

Name	Time	Method
Time-matched, placebo-corrected, change-from-baseline non-QT intervals after TD and SD of Zelicapavir	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	Up to 96 hours post dose
Cmax of zelicapavir	Up to 96 hours post dose
Tmax of zelicapavir	Up to 96 hours post dose
ΔΔQTcF after moxifloxacin dosing	Up to 24 hours post dose
Safety measured by adverse events	Up to Day 33
Time-matched, placebo-corrected, change-from-baseline HR after TD and SD of Zelicapavir	Up to 24 hours post dose
t1/2 of zelicapavir	Up to 96 hours post dose
Vd/F of zelicapavir	Up to 96 hours post dose
CL/F of zelicapavir	Up to 96 hours post dose

Trial Locations

Locations (2)

ICON Early Phase, LLC; 🇺🇸 San Antonio, Texas, United States

ICON; 🇺🇸 Lenexa, Kansas, United States