Clinical trial NCT06601192: A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: RSV Infection
QTc Interval
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time-matched, placebo-corrected change-from-baseline QTc based on the Fridericia correction QTcF (ΔΔQTcF) after TD and SD of Zelicapavir
timeFrame: Up to 24 hours post dose
Secondary outcomes:
measure: Time-matched, placebo-corrected, change-from-baseline non-QT intervals after TD and SD of Zelicapavir
timeFrame: Up to 24 hours post dose
measure: Time-matched, placebo-corrected, change-from-baseline HR after TD and SD of Zelicapavir
timeFrame: Up to 24 hours post dose
measure: Concentration-QTc analysis based on the relationship between plasma concentrations of zelicapavir and ΔΔQTcF after a TD and SD of zelicapavir
timeFrame: Up to 96 hours post dose
measure: Cmax of zelicapavir
timeFrame: Up to 96 hours post dose
measure: Tmax of zelicapavir
timeFrame: Up to 96 hours post dose
measure: t1/2 of zelicapavir
timeFrame: Up to 96 hours post dose
measure: Vd/F of zelicapavir
timeFrame: Up to 96 hours post dose
measure: CL/F of zelicapavir
timeFrame: Up to 96 hours post dose
measure: ΔΔQTcF after moxifloxacin dosing
timeFrame: Up to 24 hours post dose
measure: Safety measured by adverse events
timeFrame: Up to Day 33
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON
state: Kansas
city: San Antonio
country: United States
facility: ICON Early Phase, LLC
state: Texas
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References: