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Thorough QT/QTc of Pritelivir in Healthy Subjects

NCT05671029 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-03-14

Study results available
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Summary

This Phase 1 clinical trial was a double-blind, single-center, randomized and placebo-controlled trial in which healthy male and female subjects received in 2 parallel-groups daily oral doses of pritelivir (Group 1) or matching placebo (Group 2). Within Group 2, a single oral administration of moxifloxacin (positive control) and corresponding matching placebo was administered in a 2-sequence crossover design (nested crossover).

Conditions

  • Healthy Subjects

Interventions

DRUG

Pritelivir and moxifloxacin placebo

oral administration

DRUG

Pritelivir placebo, moxifloxacin and moxifloxacin placebo

oral administration

DRUG

Pritelivir placebo, moxifloxacin placebo and moxifloxacin

oral administration

Sponsors & Collaborators

  • AiCuris Anti-infective Cures AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-04
Primary Completion
2023-05-18
Completion
2023-05-18
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05671029 on ClinicalTrials.gov