QTc Interval, RSV Infection
Conditions
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.
Interventions
DRUGzelicapavir (therapeutic dose)
Subjects will receive zelicapavir (TD) once per treatment period.
DRUGzelicapavir (supratherapeutic dose)
Subjects will receive zelicapavir (SD) once per treatment period.
DRUGPlacebo
Subjects will receive zelicapavir matching placebo once per treatment period.
DRUGmoxifloxacin
Subjects will receive moxifloxin once per treatment period.
Sponsors
Enanta Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Time-matched, placebo-corrected, change-from-baseline non-QT intervals after TD and SD of Zelicapavir | Up to 24 hours post dose |
| Time-matched, placebo-corrected, change-from-baseline HR 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 |
| ΔΔQTcF after moxifloxacin dosing | 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 |
| Safety measured by adverse events | Up to Day 33 |
| Tmax of zelicapavir | Up to 96 hours post dose |
Countries
United States
Outcome results
None listed