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

Enanta Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: RSV Infection; QTc Interval

Treatments: Drug: zelicapavir (supratherapeutic dose); Drug: moxifloxacin; Drug: zelicapavir (therapeutic dose); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06601192

EDP 938-008

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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72 participants in 4 patient groups, including a placebo group

zelicapavir Dose 1 (therapeutic dose)

Experimental group

Description:

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.

Treatment:

Drug: zelicapavir (therapeutic dose)

zelicapavir Dose 2 (supratherapeutic dose)

Experimental group

Description:

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.

Treatment:

Drug: zelicapavir (supratherapeutic dose)

placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

moxifloxacin

Experimental group

Description:

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.

Treatment:

Drug: moxifloxacin