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Zelicapavir's Effect on Heart Rhythm

Phase 1

Recruiting

Research Sponsored by Enanta Pharmaceuticals, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female individuals who are 18 to 65 years of age, inclusive

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

Must not have

Pregnant or nursing females

Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial aims to see how different doses of zelicapavir affect the heart's QT interval compared to a placebo and another drug in healthy participants.

Who is the study for?

This trial is for healthy adults who can participate in a study to understand how different doses of a drug called Zelicapavir affect the heart's electrical cycle compared to a placebo and another drug, moxifloxacin. Specific eligibility criteria are not provided.

What is being tested?

The study tests the effects of two doses of Zelicapavir (one normal and one high) on the heart's QT interval, which represents part of the electrical cycle during heartbeats, against an inactive substance (placebo) and moxifloxacin as a control.

What are the potential side effects?

Potential side effects were not detailed; however, since it involves cardiac monitoring, participants may experience changes in heartbeat or other heart-related symptoms. Moxifloxacin may cause nausea, diarrhea, headache or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I agree to use two forms of birth control during and 30 days after the study.

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My BMI is between 18 and 30, and I weigh at least 50 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or nursing.

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I have a condition that could affect how my body absorbs medication.

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I have smoked or used tobacco products within the last 3 months.

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I am infected with HIV, HBV, HCV, or COVID-19.

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I have not had a fever or active infection in the last 7 days.

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I haven't received any vaccines or investigational drugs within the last 28 days or longer, depending on the drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: zelicapavir Dose 2 (supratherapeutic dose)Experimental Treatment1 Intervention

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.

Group II: zelicapavir Dose 1 (therapeutic dose)Experimental Treatment1 Intervention

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.

Group III: moxifloxacinExperimental Treatment1 Intervention

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.

Group IV: placeboPlacebo Group1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

moxifloxacin

2008

Completed Phase 4

~4260

0 / 9Eligibility criteria met